Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04370431
Registration number
NCT04370431
Ethics application status
Date submitted
18/04/2020
Date registered
1/05/2020
Date last updated
2/04/2021
Titles & IDs
Public title
A Study of TTYP01 in Healthy Adult Subjects
Query!
Scientific title
A Phase I, Single Center, Randomized, Single-Ascending Dose, Pharmacokinetic and Safety Study (Part A), Bioavailability Comparison Study (Part B) and Food Effect Study (Part C) in Healthy Adult Subjects.
Query!
Secondary ID [1]
0
0
Auzone-01
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Healthy Adult Subjects
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - TTYP01 single ascending doses
Treatment: Drugs - Placebo
Treatment: Drugs - TTYP01, 60 mg
Treatment: Drugs - TTYP01, 120 mg
Treatment: Drugs - Radicut® (ampoule), 30 mg
Treatment: Drugs - Radicut® (bag) , 60 mg
Treatment: Drugs - TTYP01, up to 120 mg
Experimental: PartA: TTYP01 single ascending doses - In Part A: a single-ascending-dose (SAD) escalation study with four consecutive cohorts, single ascending doses of TTYP01 (60, 120, 180 and 240 mg) will be orally administrated.
Placebo comparator: Part A: Placebo - Placebo control for Part A of the study
Experimental: Part B: TTYP01 (oral edaravone) first then IV edaravone - Randomized, Open-label, Four-period and Crossover design. A single dose of edaravone in each treatment period. Period 1: 60 mg oral edaravone tablet (TTYP01); Period 2: 30 mg IV edaravone (Radicut® ampoule), Period 3: 120 mg oral edaravone tablet (TTYP01); Period 4: 60 mg IV edaravone (Radicut® bag). Each dose will be spearated by a minimum of 7 days washout period.
Experimental: Part B: IV edaravone first then TTYP01 (oral edaravone) - Randomized, Open-label, Four-period and Crossover design. A single dose of edaravone in each treatment period. Period 1: 30 mg IV edaravone (Radicut® ampoule); Period 2: 60 mg oral edaravone tablet (TTYP01); Period 3: 60 mg IV edaravone (Radicut® bag); Period 4: 120 mg oral edaravone tablet (TTYP01). Each dose will be spearated by a minimum of 7 days washout period.
Experimental: Part C: TTYP01: fasted dosing first then fed dosing - Randomized, open-Label, Two-period and Crossover design. A fix oral dose of TTYP01 tablet in each treatment period. Period 1: under fasted condition; Period 2: under fed condition. Each dose will be spearated by a minimum of 7 days washout period.
Experimental: Part C: TTYP01: fed dosing first then fasted dosing - Randomized, open-Label, Two-period and Crossover design. A fix oral dose of TTYP01 tablet in each treatment period. Period 1: under fed condition; Period 2: under fasted condition. Each dose will be spearated by a minimum of 7 days washout period.
Treatment: Drugs: TTYP01 single ascending doses
TTYP01 (30 mg edaravone tablet) will be orally administrated at single ascending doses of 60 mg, 120 mg, 180 mg and 240 mg (n=6 per dose)
Treatment: Drugs: Placebo
Placebo control for Part A of the study
Treatment: Drugs: TTYP01, 60 mg
TTYP01 oral tablets (30 mg edaravone per tablet)
Treatment: Drugs: TTYP01, 120 mg
TTYP01 oral tablets (30 mg edaravone per tablet)
Treatment: Drugs: Radicut® (ampoule), 30 mg
An intravenous dose of edaravone injection, containing 30 mg edaravone in a 20 mL ampoule, will be administered at a dose of 30 mg over 30 minutes
Treatment: Drugs: Radicut® (bag) , 60 mg
An intravenous dose of edaravone injection, containing 30 mg edaravone in a 100 mL injection bag, will be administered at a dose of 60 mg over 60 minutes
Treatment: Drugs: TTYP01, up to 120 mg
TTYP01 oral tablets (30 mg edaravone per tablet). The fixed oral dose level of TTYP01 will depend on the results obtained in Part B of the study (no more than 120 mg)
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Adverse events
Query!
Assessment method [1]
0
0
Frequencies (number and percentage) of subjects with one or more AEs
Query!
Timepoint [1]
0
0
until the last follow-up visit, up to 4 weeks
Query!
Primary outcome [2]
0
0
change in hemoglobin (g/L)
Query!
Assessment method [2]
0
0
measured by hematology test
Query!
Timepoint [2]
0
0
up to 6 days post each dose
Query!
Primary outcome [3]
0
0
change in hematocrit (ratio)
Query!
Assessment method [3]
0
0
measured by hematology test
Query!
Timepoint [3]
0
0
up to 6 days post each dose
Query!
Primary outcome [4]
0
0
change in red blood cell count (cells x 10^12/L)
Query!
Assessment method [4]
0
0
measured by hematology test
Query!
Timepoint [4]
0
0
up to 6 days post each dose
Query!
Primary outcome [5]
0
0
change in white blood cell (WBC) count (cells x 10^9/L)
Query!
Assessment method [5]
0
0
measured by hematology test
Query!
Timepoint [5]
0
0
up to 6 days post each dose
Query!
Primary outcome [6]
0
0
change in platelet count (cells x 10^9/L)
Query!
Assessment method [6]
0
0
measured by hematology test
Query!
Timepoint [6]
0
0
up to 6 days post each dose
Query!
Primary outcome [7]
0
0
change in total neutrophils count (cells x 10^9/L)
Query!
Assessment method [7]
0
0
measured by hematology test
Query!
Timepoint [7]
0
0
up to 6 days post each dose
Query!
Primary outcome [8]
0
0
change in lymphocytes count (cells x 10^9/L)
Query!
Assessment method [8]
0
0
measured by hematology test
Query!
Timepoint [8]
0
0
up to 6 days post each dose
Query!
Primary outcome [9]
0
0
change in monocytes count (cells x 10^9/L)
Query!
Assessment method [9]
0
0
measured by hematology test
Query!
Timepoint [9]
0
0
up to 6 days post each dose
Query!
Primary outcome [10]
0
0
change in eosinophils count (cells x 10^9/L)
Query!
Assessment method [10]
0
0
measured by hematology test
Query!
Timepoint [10]
0
0
up to 6 days post each dose
Query!
Primary outcome [11]
0
0
change in basophils count (cells x 10^9/L)
Query!
Assessment method [11]
0
0
measured by hematology test
Query!
Timepoint [11]
0
0
up to 6 days post each dose
Query!
Primary outcome [12]
0
0
change in serum sodium (mmol/L)
Query!
Assessment method [12]
0
0
measured by serum chemistry
Query!
Timepoint [12]
0
0
up to 6 days post each dose
Query!
Primary outcome [13]
0
0
change in serum potassium (mmol/L)
Query!
Assessment method [13]
0
0
measured by serum chemistry
Query!
Timepoint [13]
0
0
up to 6 days post each dose
Query!
Primary outcome [14]
0
0
change in serum chloride (mmol/L)
Query!
Assessment method [14]
0
0
measured by serum chemistry
Query!
Timepoint [14]
0
0
up to 6 days post each dose
Query!
Primary outcome [15]
0
0
change in serum calcium (mmol/L)
Query!
Assessment method [15]
0
0
measured by serum chemistry
Query!
Timepoint [15]
0
0
up to 6 days post each dose
Query!
Primary outcome [16]
0
0
change in serum glucose (mmol/L)
Query!
Assessment method [16]
0
0
measured by serum chemistry
Query!
Timepoint [16]
0
0
up to 6 days post each dose
Query!
Primary outcome [17]
0
0
change in serum urea (mmol/L)
Query!
Assessment method [17]
0
0
measured by serum chemistry
Query!
Timepoint [17]
0
0
up to 6 days post each dose
Query!
Primary outcome [18]
0
0
change in serum creatinine (umol/L)
Query!
Assessment method [18]
0
0
measured by serum chemistry
Query!
Timepoint [18]
0
0
up to 6 days post each dose
Query!
Primary outcome [19]
0
0
change in serum total bilirubin (umol/L)
Query!
Assessment method [19]
0
0
measured by serum chemistry
Query!
Timepoint [19]
0
0
up to 6 days post each dose
Query!
Primary outcome [20]
0
0
change in aspartate aminotransferase (AST) (U/L)
Query!
Assessment method [20]
0
0
measured by serum chemistry
Query!
Timepoint [20]
0
0
up to 6 days post each dose
Query!
Primary outcome [21]
0
0
change in alanine aminotransferase (ALT) (U/L)
Query!
Assessment method [21]
0
0
measured by serum chemistry
Query!
Timepoint [21]
0
0
up to 6 days post each dose
Query!
Primary outcome [22]
0
0
change in alkaline phosphatase (ALP) (U/L)
Query!
Assessment method [22]
0
0
measured by serum chemistry
Query!
Timepoint [22]
0
0
up to 6 days post each dose
Query!
Primary outcome [23]
0
0
change in serum creatine kinase (CK) (U/L)
Query!
Assessment method [23]
0
0
measured by serum chemistry
Query!
Timepoint [23]
0
0
up to 6 days post each dose
Query!
Primary outcome [24]
0
0
change in serum albumin (g/L)
Query!
Assessment method [24]
0
0
measured by serum chemistry
Query!
Timepoint [24]
0
0
up to 6 days post each dose
Query!
Primary outcome [25]
0
0
change in serum phosphate (mmol/L)
Query!
Assessment method [25]
0
0
measured by serum chemistry
Query!
Timepoint [25]
0
0
up to 6 days post each dose
Query!
Primary outcome [26]
0
0
change in serum lipase (U/L)
Query!
Assessment method [26]
0
0
measured by serum chemistry
Query!
Timepoint [26]
0
0
up to 6 days post each dose
Query!
Primary outcome [27]
0
0
change in serum total protein (g/L)
Query!
Assessment method [27]
0
0
measured by serum chemistry
Query!
Timepoint [27]
0
0
up to 6 days post each dose
Query!
Primary outcome [28]
0
0
change in urine pH
Query!
Assessment method [28]
0
0
measured by urinalysis
Query!
Timepoint [28]
0
0
up to 6 days post each dose
Query!
Primary outcome [29]
0
0
change in urine specific gravity
Query!
Assessment method [29]
0
0
measured by urinalysis
Query!
Timepoint [29]
0
0
up to 6 days post each dose
Query!
Primary outcome [30]
0
0
change in urine glucose
Query!
Assessment method [30]
0
0
measured by urinalysis
Query!
Timepoint [30]
0
0
up to 6 days post each dose
Query!
Primary outcome [31]
0
0
change in urine protein
Query!
Assessment method [31]
0
0
measured by urinalysis
Query!
Timepoint [31]
0
0
up to 6 days post each dose
Query!
Primary outcome [32]
0
0
change in urine ketones
Query!
Assessment method [32]
0
0
measured by urinalysis
Query!
Timepoint [32]
0
0
up to 6 days post each dose
Query!
Primary outcome [33]
0
0
change in urine blood
Query!
Assessment method [33]
0
0
measured by urinalysis
Query!
Timepoint [33]
0
0
up to 6 days post each dose
Query!
Primary outcome [34]
0
0
change in urine casts
Query!
Assessment method [34]
0
0
measured by microscopic analysis, if any abnormalities in urinalysis are detected
Query!
Timepoint [34]
0
0
up to 6 days post each dose
Query!
Primary outcome [35]
0
0
change in urine crystals
Query!
Assessment method [35]
0
0
measured by microscopic analysis, if any abnormalities in urinalysis are detected
Query!
Timepoint [35]
0
0
up to 6 days post each dose
Query!
Primary outcome [36]
0
0
change in urine epithelial cells
Query!
Assessment method [36]
0
0
measured by microscopic analysis, if any abnormalities in urinalysis are detected
Query!
Timepoint [36]
0
0
up to 6 days post each dose
Query!
Primary outcome [37]
0
0
change in urine bacteria (cfu/L)
Query!
Assessment method [37]
0
0
measured by microscopic analysis, if any abnormalities in urinalysis are detected
Query!
Timepoint [37]
0
0
up to 6 days post each dose
Query!
Primary outcome [38]
0
0
change in urine red blood cells (Cells x 10^9/L)
Query!
Assessment method [38]
0
0
measured by microscopic analysis, if any abnormalities in urinalysis are detected
Query!
Timepoint [38]
0
0
up to 6 days post each dose
Query!
Primary outcome [39]
0
0
change in urine white blood cells (Cells x 10^9/L)
Query!
Assessment method [39]
0
0
measured by microscopic analysis, if any abnormalities in urinalysis are detected
Query!
Timepoint [39]
0
0
up to 6 days post each dose
Query!
Primary outcome [40]
0
0
change in systolic blood pressure (mmHg)
Query!
Assessment method [40]
0
0
Query!
Timepoint [40]
0
0
up to 6 days post each dose
Query!
Primary outcome [41]
0
0
change in diastolic blood pressure (mmHg)
Query!
Assessment method [41]
0
0
Query!
Timepoint [41]
0
0
up to 6 days post each dose
Query!
Primary outcome [42]
0
0
change in pulse rate (bpm)
Query!
Assessment method [42]
0
0
Query!
Timepoint [42]
0
0
up to 6 days post each dose
Query!
Primary outcome [43]
0
0
change in body temperature (celsius)
Query!
Assessment method [43]
0
0
Query!
Timepoint [43]
0
0
up to 6 days post each dose
Query!
Primary outcome [44]
0
0
Change in QT intervals (msec)
Query!
Assessment method [44]
0
0
Measured using a 12 Lead Electrocardiogram
Query!
Timepoint [44]
0
0
up to 6 days post each dose
Query!
Primary outcome [45]
0
0
Change in RR intervals (msec)
Query!
Assessment method [45]
0
0
Measured using a 12 Lead Electrocardiogram
Query!
Timepoint [45]
0
0
up to 6 days post each dose
Query!
Primary outcome [46]
0
0
Change in PR intervals (msec)
Query!
Assessment method [46]
0
0
Measured using a 12 Lead Electrocardiogram
Query!
Timepoint [46]
0
0
up to 6 days post each dose
Query!
Primary outcome [47]
0
0
Change in QRS duration (msec)
Query!
Assessment method [47]
0
0
Measured using a 12 Lead Electrocardiogram
Query!
Timepoint [47]
0
0
up to 6 days post each dose
Query!
Primary outcome [48]
0
0
Change in corrected QTcF (msec)
Query!
Assessment method [48]
0
0
Calculated using measurements by a 12 Lead Electrocardiogram
Query!
Timepoint [48]
0
0
up to 6 days post each dose
Query!
Primary outcome [49]
0
0
clinically significant abnormality in brief physical examinations
Query!
Assessment method [49]
0
0
clinically significant abnormality in skin, lungs, cardiovascular system, and abdomen (spleen and liver)
Query!
Timepoint [49]
0
0
up to 6 days post each dose
Query!
Secondary outcome [1]
0
0
Maximum observed plasma concentration (Cmax)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
up to 24 hours post each dose
Query!
Secondary outcome [2]
0
0
Time of maximum plasma concentration (Tmax)
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
up to 24 hours post each dose
Query!
Secondary outcome [3]
0
0
Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
up to 24 hours post each dose
Query!
Secondary outcome [4]
0
0
Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last)
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
up to 24 hours post each dose
Query!
Secondary outcome [5]
0
0
The ratio of area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last) extrapolated to AUC0-inf over AUC0-inf (% AUCex)
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
up to 24 hours post each dose
Query!
Secondary outcome [6]
0
0
Apparent volume of distribution (Vd/F)
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
up to 24 hours post each dose
Query!
Secondary outcome [7]
0
0
Terminal half-life(T1/2)
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
up to 24 hours post each dose
Query!
Secondary outcome [8]
0
0
Apparent oral clearance (CL/F)
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
up to 24 hours post each dose
Query!
Secondary outcome [9]
0
0
Mean retention time (MRT)
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
up to 24 hours post each dose
Query!
Secondary outcome [10]
0
0
Lambda z - the reciprocal of elimination rate constant (?z)
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
up to 24 hours post each dose
Query!
Secondary outcome [11]
0
0
Fabs-bioavailability value (Fabs)
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
up to 24 hours post each dose
Query!
Eligibility
Key inclusion criteria
* Age between 18 and 40, inclusive;
* Non-smokers, ex-smokers and moderate smokers will be included. "A moderate smoker is defined as someone smoking 5 cigarettes or less per day, an ex-smoker is someone who completely stopped smoking for at least 3 months.";
* If female, must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception (e.g., oral, intrauterine device [IUD; diaphragm], injectable, transdermal or implantable contraception) or abstinence, for at least 1 month prior to randomization, during the study and 3 month following completion of the study. Females of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening;
* Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive; and a total body weight >50 kg at screening for male subjects, total body weight > 45 kg for female subjects;
* Female subjects of child bearing potential and all male participants who have not had a vasectomy must use effective contraception during the study
* Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the subject prior to any study-specific procedures), and evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
* Willingness and ability to comply with study procedures and follow-up examination.
* Adequate organ function as evidenced by the following peripheral blood counts or serum chemistry values within 28 days before randomization:
1. Hemoglobin greater than or equal to 9 g/dL
2. Neutrophil count (ANC) greater than or equal to 1,500/microL
3. Platelet count greater than or equal to 100,000/microL
4. Serum creatinine less than or equal to 1.5 mg/dL (less than or equal to 132.6 micromol/L) and creatinine clearance greater than or equal to 60 ml/min
5. Creatine phosphokinase (CPK) less than or equal to 2x upper limit of normal (ULN)
6. Hepatic function variables:
1. Total bilirubin = 1.5x ULN
2. Total alkaline phosphatase (ALP) = 1.5x ULN, or if > 1.5x ULN, then ALP liver fraction or 5' nucleotidase must be =1x ULN
3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be = 2.5x ULN
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
40
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Subjects with a history of hypersensitivity to edaravone or any of the inactive ingredients of the formulation (such as sulfite and sodium bisulfite).
* Subjects with PR >240 msec, QRS =120 msec, or QTcF >450 msec for male & QTcF >470 msec for female on the screening or Day -1 ECG, or any clinically significant electrocardiographic abnormality in the opinion of the investigator.
* Male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 3 months after the last dose of investigational product.
* Female subjects currently pregnant or lactating; female subjects able to bear children or of child bearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 3 months after the last dose of investigational product.
* Subjects whose urine drug/alcohol screening was positive at the time of screening and/or on Day-1.
* Subjects having difficulty in swallowing pills/tablets.
* Subjects smoking > 5 cigarettes per day within 3 months prior to the screening visit.
* Subjects unwilling or unable to comply with the Lifestyle Guidelines described in the protocol.
* Subjects who are investigational site staff members directly involved in the conduct of the studies and their family members, site staff members otherwise supervised by the Investigator, or subjects who are the sponsors' employees directly involved in the conduct of the studies.
* Evidence of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
* Subjects who have participated in another clinical trial less than 3 months before or donated his/her blood in a quantity greater than 200 milliliters (mL) within 1 month of the screening period of this clinical trial.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
24/04/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
8/01/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
72
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Recruitment hospital [1]
0
0
CMAX Clinical Research Pty Ltd - Adelaide
Query!
Recruitment postcode(s) [1]
0
0
5000 - Adelaide
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Auzone Biological Technology Pty Ltd
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
TIGERMED AUSTRALIA PTY LIMITED
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
CMAX Clinical Research Pty Ltd
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is integrated Phase 1, Single centre, Randomized study will be conducted in 3 parts, each with a specific primary objective: Part A: To characterise the safety and tolerability of TTYP01 in healthy adult subjects; Part B: To evaluate the bioavailability of TTYP01 tablets in healthy adult subjects; Part C: To characterise the food effect of TTYP01 tablets in healthy adult subjects under the fasted or fed condition. The secondary objectives of the study are to evaluate the pharmacokinetic (PK) profiles of TTYP01 tablets in healthy adult subjects, and the effects of gender on the PK of TTYP01 tablets in healthy adults. In Part A of the study, a total of 32 healthy adult subjects will be enrolled over four consecutive cohorts (8 per cohort), with participants receiving a single dose of TTYP01 at one of four levels (60, 120, 10 or 240 mg), to assess the PK and safety of TTYP01. In Part B, 16 healthy adults will be randomized into 2 groups, and the comparison of the PK of edaravone (TTYP01 and intravenous (IV) edaravone) will be evaluated using a randomized, open-label, four-period crossover design under fasted conditions. In the first crossover period, subjects will receive a single fixed dose of TTYP01 followed by the alternate IV dose after completion of the washout phase, and in the second crossover period, subjects will receive a higher fixed dose of TTYP01 followed by the alternate IV dose after completion of the washout phase. In Part C, 18 healthy subjects will be enrolled to evaluate the effect of food on the PK of TTYP01 using a randomized, open-label, two-period cross-over design. Participants will be randomized into two groups and administered a fixed dose of TTYP01 on Day 1 (Period 1) under the fed conditions and the second dosing day (Period 2) under the fasted conditions, while the other group being administered a fixed dose of TTYP01 on Day 1 (Period 1) under the fasted conditions and the second dosing day (Period 2) under the fed conditions.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04370431
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Sepehr Shakib, MD
Query!
Address
0
0
Royal Adelaide Hospital
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04370431
Download to PDF