Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000148673
Ethics application status
Approved
Date submitted
15/11/2022
Date registered
15/02/2023
Date last updated
15/05/2023
Date data sharing statement initially provided
15/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Open-Label, Randomized, Fasted, Single Oral Dose, Crossover Trial to Assess the Relative Bioavailability of FP-045 and its Metabolite AD-835 After Single Doses of FP-045 2 X 75 mg Capsules (Test Drug) Compared to 150 mg Reconstituted FP-045 Drug Substance Liquid Formulation (Reference Drug) in Healthy Male Participants
Scientific title
Open-Label, Randomized, Fasted, Single Oral Dose, Crossover Trial to Assess the Relative Bioavailability of FP-045 and its Metabolite AD-835 After Single Doses of FP-045 2 X 75 mg Capsules (Test Drug) Compared to 150 mg Reconstituted FP-045 Drug Substance Liquid Formulation (Reference Drug) in Healthy Male Participants
Secondary ID [1] 308045 0
FP045C-22-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fanconi anaemia 327761 0
Condition category
Condition code
Blood 324831 324831 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Approximately 8 participants will be enrolled in this study.

Study participants will receive a single 150mg dose of FP-045. FP-045 will be administered once only, orally as two 75mg capsules. Participants must fast for at least 10 hours prior to administration. Administration will occur under supervision.

There will be a 5 day wash out period between treatments (120 hours).
Intervention code [1] 324518 0
Treatment: Drugs
Comparator / control treatment
Participants will also receive the reconstituted powder formulation of FP-045 (150mg test drug) administered once only in 20 mL of Ocean Spray cranberry classic juice. Participants must fast for at least 10 hours prior to administration. Administration will occur under supervision.
Control group
Active

Outcomes
Primary outcome [1] 332648 0
To assess the relative bioavailability of FP-045 after single, oral doses of FP-045 capsules (test) versus reconstituted drug (reference) product administered to healthy male participants under fasting conditions. Bioavailability will be assessed by measurement of Plasma Pharmacokinetics (PK) parameters AUClast (area under the curve to last available data point or infinity) and Cmax (maximum observed concentration) for FP-045.
Timepoint [1] 332648 0
Following enrollment into the study and administration of the study drug, participants will undergo PK testing at the following defined time points: Pre dose, 10mins, 15 mins, 30mins, 45mins, 1hr, 1hr20mins, 1hr40mins, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 5hr, 6hr, 8hr, 10hr, 14hr, 24hr, 48hr and 72hr post dose.
Primary outcome [2] 333175 0
To assess the relative bioavailability of metabolite AD-835 after single, oral doses of FP-045 capsules (test) versus reconstituted drug (reference) product administered to healthy male participants under fasting conditions. Bioavailability will be assessed by measurement of Plasma Pharmacokinetics (PK) parameters AUClast (area under the curve to last available data point or infinity) and Cmax (maximum observed concentration) for AD-835.
Timepoint [2] 333175 0
Following enrollment into the study and administration of the study drug participants will undergo PK testing at the following defined time points: Pre dose, 10mins, 15mins, 30mins, 45mins, 1hr, 1hr20mins, 1hr40mins, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 5hr, 6hr, 8hr, 10hr, 14hr, 24hr, 48hr and 72hr post dose.
Secondary outcome [1] 414226 0
To assess additional PK plasma parameters of FP-045 after single, oral doses of FP-045 capsules (test) versus reconstituted drug (reference) product administered to healthy male participants under fasting conditions. Additional PK parameters include measurement of AUCinf, tmax, and t½ for FP-045.
Timepoint [1] 414226 0
Sampling for PK plasma analysis will occur at the following time points: Pre dose, 10mins, 15 mins, 30mins, 45mins, 1hr, 1hr20mins, 1hr40mins, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 5hr, 6hr, 8hr, 10hr, 14hr, 24hr, 48hr and 72hr post dose.
Secondary outcome [2] 414228 0
To assess the safety and tolerability of single, oral doses of FP-045 capsules (test) versus reconstituted drug (reference) product administered to healthy male participants under fasting conditions. Safety will be measured by routine clinical and laboratory procedures including blood samples to assess haematology, coagulation, liver function, renal function and metabolic blood chemistry; glucose testing via glucometer or via cannula; urinalysis; physical examination; collection of vital signs including measurement of blood pressure measured using a sphygmomanometer, heart rate, respiratory rate and temperature; ECG and recording of treatment-emergent adverse events and serious adverse events in accordance with the International Committee on Harmonization (ICH) Clinical Safety Data Management Guidance for Industry, E2A, and 21 CFR Parts 312.32. Possible adverse events include headache, abdominal distension or nausea.
Timepoint [2] 414228 0
Following enrollment into the study and administration of the first dose of study drug participants will undergo vital signs measurements comprising blood pressure, heart rate, respiratory rate and temperature on days 1, 2, 5, 6, 7 and day 9 visits. On days 1 and 6, vital signs will be obtained 0.5, 1, and 2 hours post dose. Only temperature will be measured at days 3, 4, and 8 post dose. Physical examination will occur on day 5 and day 9 post dose. Clinical laboratory tests including chemistry, hematology, coagulation and urinalysis will be collected during screening and on Days 4, 5 and 9 post dose as well as glucose monitoring on days 1-3 with either a glucometer or blood draw via cannula. A 12lead ECG will be performed during screening and on day 4 and day 9 post dose. Adverse events will be assessed from the time of informed consent through day 9 post dose.
Secondary outcome [3] 416055 0
To assess additional PK plasma parameters of metabolite AD-835 after single, oral doses of FP-045 capsules (test) versus reconstituted drug (reference) product administered to healthy male participants under fasting conditions. Additional PK parameters include measurement of AUCinf, tmax, and t½ for AD-835.
Timepoint [3] 416055 0
Sampling for PK plasma analysis will occur at the following time points: Pre dose, 10mins, 15 mins, 30mins, 45mins, 1hr, 1hr20mins, 1hr40mins, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 5hr, 6hr, 8hr, 10hr, 14hr, 24hr, 48hr and 72hr post dose.

Eligibility
Key inclusion criteria
- Male participants between 18 to 55 years of age inclusive.
- Nonsmoker, ex-smoker, or light smoker who smokes <5 cigarettes/week and agrees to no smoking for 5 days before admission and has a negative urine cotinine test at admission (day -1).
- Participants who are overtly healthy based on assessment of medical history, physical examination, vital signs, ECGs, hematology, chemistry, and urinalysis assessments, serology, and other assessments.
- Body mass index between 18 and 32 kg/m2 inclusive.
- Males with female partners of childbearing potential agree to use a barrier contraceptive (ie, condom) and their female partners agree to use a highly effective method of contraception from Screening through 90 days after the last dose of the study drug. Males will agree to refrain from sperm donations during this time period. Males who are abstinent will not be required to use a contraceptive method unless they become sexually active.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History or presence of any clinically significant neurological, metabolic, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, chronic infections, psychiatric, or genitourinary abnormalities or diseases.
- History of malignant neoplastic disease, except for adequately treated non-melanomatous skin carcinoma.
- Mentally or legally incapacitated, had significant emotional problems at Screening or expected during the conduct of the study, or had a history of a clinically significant psychiatric disorder within 5 years before Screening.
- The participant has had a history of severe drug allergy or hypersensitivity or food allergy, including anaphylaxis.
- The participant has had surgery or trauma with significant blood loss within the last 3 months before the first dose of FP-045.
- The participant has donated more than 1 unit (500 mL) of blood within 4 weeks or plasma within one week before the first dose of FP-045.
- Clinically significant laboratory abnormalities including:
- Positive test for hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus antibody at Screening.
- Positive screen for drugs with a high potential for abuse.
- The participant exercises extensively (eg, marathon, triathlon, or similar high energy sports).
- A history or presence of any clinically significant endocrinologic abnormality or disease
- Use of prescription medications within 7 days (or within 5 half-lives, whichever is longer) of the first dose of FP-045.

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)
Copies of the randomization sequence and treatment codes will be kept in the pharmacy at the Clinical Research Unit. Pharmacy (or other qualified site) personnel will be utilized to prepare the study drug for this trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a single center Phase 1 study; the study site’s Pharmacist (or qualified designee) will obtain the study drug assignment from a computer-generated randomization code list, by cohort, using a validated random generator software. The randomization scheme and codes will be generated by a Statistician and provided to the site prior to study commencement.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-availability
Statistical methods / analysis
For plasma AD-835 and separately for FP-045 relative bioavailability will be assessed separately for the participants crossover using the natural log transformed AUClast and Cmax PK parameters. Plasma samples from subjects in the PK Analysis will be analyzed for the concentration of FP-045 and active metabolite AD-835. Concentrations of FP-045 and AD-835 and PK parameters will be summarized by visit and nominal time points and compared using graphics and descriptive statistics. Individual FP-045 and AD-835 plasma concentrations at specified timepoints will be listed for each participant and will be summarized by formulation. Individual plasma concentration-time profiles of FP-045 and AD-835 will be plotted on both a linear and a semi-logarithmic scale for each formulation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/12/2022
Date of last participant enrolment
Anticipated
Actual
14/12/2022
Date of last data collection
Anticipated
28/02/2023
Actual
28/02/2023
Sample size
Target
8
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23233 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 38602 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 312302 0
Commercial sector/Industry
Name [1] 312302 0
Foresee Pharmaceuticals Co., Ltd.
Country [1] 312302 0
Taiwan, Province Of China
Primary sponsor type
Commercial sector/Industry
Name
Foresee Pharmaceuticals Co., Ltd.
Address
9F-2, No. 19-3, Sanchong Rd. Nangang District,
Taipei City 115, Taiwan (R.O.C.)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 313879 0
Commercial sector/Industry
Name [1] 313879 0
InClin Pty Ltd
Address [1] 313879 0
210 / 25-29 Berry Street
North Sydney, NSW
Australia, 2060
Country [1] 313879 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311671 0
Bellberry Limited HREC
Ethics committee address [1] 311671 0
Ethics committee country [1] 311671 0
Australia
Date submitted for ethics approval [1] 311671 0
05/10/2022
Approval date [1] 311671 0
10/11/2022
Ethics approval number [1] 311671 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121938 0
Dr Sam Francis
Address 121938 0
Nucleus Network Melbourne, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne 3004, Victoria
Country 121938 0
Australia
Phone 121938 0
+61 466 640 801
Fax 121938 0
Email 121938 0
[email protected]
Contact person for public queries
Name 121939 0
Taylor Kilfoil
Address 121939 0
InClin Pty. Ltd.
210 / 25-29 Berry Street
North Sydney, NSW
Australia, 2060
Country 121939 0
Australia
Phone 121939 0
+61 408 880 403
Fax 121939 0
Email 121939 0
[email protected]
Contact person for scientific queries
Name 121940 0
Taylor Kilfoil
Address 121940 0
InClin Pty. Ltd.
210 / 25-29 Berry Street
North Sydney, NSW
Australia, 2060
Country 121940 0
Australia
Phone 121940 0
+61 408 880 403
Fax 121940 0
Email 121940 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.