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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02297594




Registration number
NCT02297594
Ethics application status
Date submitted
11/11/2014
Date registered
21/11/2014
Date last updated
20/10/2015

Titles & IDs
Public title
Safety, Tolerability and PK Study of AK0529 in Healthy Human
Scientific title
A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of AK0529 When Administered Orally in Healthy Male and Female Adult Subjects
Secondary ID [1] 0 0
AK0529-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AK0529
Treatment: Drugs - Placebo

Experimental: AK0529 - Generic name: AK0529 Dosage Form: capsule

Placebo Comparator: Placebo - Sugar placebo


Treatment: Drugs: AK0529
AK0529 capsule for oral administration

Treatment: Drugs: Placebo
Sugar placebo capsule for oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events, serious adverse events
Timepoint [1] 0 0
Screening to Day 14 - 21
Secondary outcome [1] 0 0
Pharmacokinetics of single dose study: Area Under Curve (AUC)
Timepoint [1] 0 0
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Secondary outcome [2] 0 0
Pharmacokinetics of single dose study: Observed Maximum plasma concentration (Cmax)
Timepoint [2] 0 0
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Secondary outcome [3] 0 0
Pharmacokinetics of single dose study: half-life (t1/2)
Timepoint [3] 0 0
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Secondary outcome [4] 0 0
Pharmacokinetics of single dose study: time to maximum plasma concentration (tmax)
Timepoint [4] 0 0
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Secondary outcome [5] 0 0
Pharmacokinetics of single dose study: Volume of distribution
Timepoint [5] 0 0
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Secondary outcome [6] 0 0
Pharmacokinetics of single dose study: Clearance
Timepoint [6] 0 0
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Secondary outcome [7] 0 0
Pharmacokinetics of multiple dose study:Area Under Curve (AUC)
Timepoint [7] 0 0
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Secondary outcome [8] 0 0
Pharmacokinetics of multiple dose study: Observed Maximum plasma concentration (Cmax)
Timepoint [8] 0 0
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Secondary outcome [9] 0 0
Pharmacokinetics of multiple dose study: half-life (t1/2)
Timepoint [9] 0 0
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Secondary outcome [10] 0 0
Pharmacokinetics of multiple dose study: time to maximum plasma concentration (tmax)
Timepoint [10] 0 0
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Secondary outcome [11] 0 0
Pharmacokinetics of multiple dose study:Volume of distribution
Timepoint [11] 0 0
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Secondary outcome [12] 0 0
Pharmacokinetics of multiple dose study: clearance
Timepoint [12] 0 0
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)

Eligibility
Key inclusion criteria
1. Must be healthy males, or healthy females of non-childbearing potential or surgically
sterilized or post-menopausal (amenorrhea for at least 1 year and confirmed by a
follicle stimulating hormone [FSH] result of > 20 IU/mL).

2. Must be aged 18 to 55 years of age inclusive.

3. Must have body mass index (BMI) of 18.0 to 31.0 kg/m2 inclusive.

4. Must have total body weight =50 kg at screening but =100 Kg.

5. Must be willing and able to communicate and participate in the whole study.

6. Must provide written informed consent.

7. Must agree to use an adequate method of contraception (as defined in Section 4.2.1).

8. Must have AST, ALT, total bilirubin, urea, creatinine and hemoglobin within the
laboratory reference range at screening and Day -1.

9. Must have QTcF <450 ms, QTcB <450 ms and PR interval <210 ms for screening, Day -1 and
pre-dose ECG measurements, and not have any degree of heart block or conduction
abnormality.

10. Must have serology demonstrating they are free from infection with hepatitis B,
hepatitis C, and human immunodeficiency virus (HIV-1 and HIV-2)
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Male subjects who have currently pregnant partners or who have partners planning to
become pregnant during the duration of the study.

2. Evidence or history of clinical significant oncological, pulmonary, chronic
respiratory, hepatic, cardiovascular, hematological, metabolic, neurological,
immunological, nephrological, endocrine or psychiatric disease, or current infection.

3. Clinically relevant (as decided by the investigator and the medical monitor)
abnormalities in the ECG (12 standard leads) including any degree of heart block,
including asymptomatic bundle branch block.

4. Family history of sudden death or of congenital prolongation of the QTc interval or
known congenital prolongation of the QTc interval or any clinical condition known to
prolong the QTc interval.

5. History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.

6. Electrolyte disturbances, particularly hypokalemia hypocalcemia or hypomagnesemia.

7. Any condition that could possibly affect drug absorption, e.g. gastrectomy or
diarrhea.

8. History of post-antibiotic colitis.

9. History of any drug or alcohol abuse in the past 2 years prior to screening.

10. Regular alcohol consumption in males >21 units per week and females >14 units per week
(1 unit = 400 mL beer, 25 mL of 40% spirit or a 75 mL glass of wine).

11. Subjects who have a urine cotinine greater than 500 ng/mL at screening will be
excluded. Subjects who are tobacco users (including smokers and users of snuff,
chewing tobacco and other nicotine or nicotine-containing products) must have stopped
use at least 90 days before screening.

12. Receipt of an investigational drug or participation in another clinical research study
within 90 days prior to drug administration.

13. Subjects who are study site employees, or immediate family members of a study site or
sponsor employee.

14. Subjects who have previously been enrolled and dosed in this study, except subjects
undergoing repeat dosing in Cohort 4F (the fed PK cohort of the SAD part of the
study).

Other protocol defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
74
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd QIMR Berghofer & Royal Brisbane and Women's Hospital Campus - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shanghai Ark Biopharmaceutical Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety, tolerability and PK of single and multiple
ascending dose of AK0529 when administered orally in healthy subjects
Trial website
https://clinicaltrials.gov/ct2/show/NCT02297594
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Griffin, MD
Address 0 0
Q-Pharm Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02297594