Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000947101
Ethics application status
Approved
Date submitted
26/06/2019
Date registered
5/07/2019
Date last updated
3/11/2020
Date data sharing statement initially provided
5/07/2019
Date results information initially provided
3/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045 Administered Orally, Once Daily for 28 Days to Normal, Healthy Volunteers
Scientific title
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045 Administered Orally, Once Daily for 28 Days to Normal, Healthy Volunteers
Secondary ID [1] 298531 0
FP045C-19-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral arterial disease 313343 0
Condition category
Condition code
Cardiovascular 311785 311785 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Approximately 10 Normal Healthy Volunteers (NHV) will be enrolled in the study. Subjects will be randomized to orally receive either FP-045 (7 subjects) or placebo (3 subjects) at doses and intervals as presented below:

Active treatment will be FP-045 (powder for oral solution) for reconstitution in cranberry juice and delivered as 120 mL oral solution total dosing volume per subject's cohort.

Study participants will receive 400 mg daily oral dose of FP-045 or Placebo for 28 days.

All subjects will remain in the Clinical Research Unit (CRU) for observation until completion of all assessments on Day 31.

Dosing will take place in the morning on dosing days under the supervision of study staff.
Study drug compliance will be documented in the eCRF by recording:
The date and time of each oral administration,
The volume of each oral dose administered,
Whether or not the entire amount of each oral dose of FP-045 was administered and whether or not subject vomited after administration of the dose.
Intervention code [1] 314779 0
Treatment: Drugs
Comparator / control treatment
The placebo will be cranberry juice delivered as an oral solution that is identical to FP-045, but without FP-045.
Control group
Placebo

Outcomes
Primary outcome [1] 320464 0
To evaluate the safety and tolerability of 28 days daily dosing of orally administered FP-045 400 mg to normal, healthy volunteers (NHVs). Safety will be measured by routine clinical and laboratory procedures, physical examination, collection of vital signs and ECGS, and recording of treatment-emergent AEs and SAEs.
Timepoint [1] 320464 0
Following enrollment into the study and administration of the 1st dose of study drug subjects will undergo vital sign measurements and physical examinations on Days 1 through 31 and at End of Study/Day 35 (EOS), as well as clinical laboratory tests (chemistry, hematology, coagulation, and urinalysis) on Day 1 through 28 and on Day 31 and EOS/Day 35. A 12-lead ECG will be performed during screening, before daily dose and 15 minutes post daily dose on Days 1 through 28, Day 31 and EOS/Day 35. Concomitant medications will be recorded from dosing with study drug through Screening to Day 31 & EOS/Day 35. Adverse events will be assessed from the time of informed consent through EOS/Day 35.
Secondary outcome [1] 371701 0
To estimate the pharmacokinetic (PK) profiles of prodrug FP-045 after multiple daily, oral doses (28 doses) of FP-045 administered to NHVs. The blood concentrations of the study drugs will be listed and summarized with the number of observations, mean, geometric mean, standard deviation, median, maximum, and coefficient of variation (CV). Figures displaying blood concentrations over time as well as non-compartmental PK parameters for the study drugs will be estimated and summarized:
Cmax, Tmax, AUC0-24, AUC0-24, lambda, t1/2, CL/F and Vz/F
Timepoint [1] 371701 0
Sampling for PK analysis will occur predose on Days 1 , Day 7, Day 14, Day 21 and Day 28 (within 30 minutes before dosing) 0.25 hr, 0.5hr, 0.75hr, 1 hr, 1.5 hr, 2hr, 3hr, 4hr, 6hr, 12hr and 16hr postdose. Sampling for PK analysis will occur predose on Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25 (within 30 minutes before dosing). Sampling for PK analysis will occur at 24hr, 36 hr, 48 hr, 52, 72 hr and 96hr, 120hr and 144hr post Day 28 dose. Sampling for PK analysis will occur at EOS/ Day 35..
Secondary outcome [2] 372181 0
To estimate the pharmacokinetic (PK) profiles of active AD-835 after multiple daily, oral doses (28 doses) of FP-045 administered to NHVs. The blood concentrations of the study drugs will be listed and summarized with the number of observations, mean, geometric mean, standard deviation, median, maximum, and coefficient of variation (CV). Figures displaying blood concentrations over time as well as non-compartmental PK parameters for the study drugs will be estimated and summarized:
Cmax, Tmax, AUC0-24, AUC0-24, lambda, t1/2, CL/F and Vz/F
Timepoint [2] 372181 0
Sampling for PK analysis will occur predose on Days 1 , Day 7, Day 14, Day 21 and Day 28 (within 30 minutes before dosing) 0.25 hr, 0.5hr, 0.75hr, 1 hr, 1.5 hr, 2hr, 3hr, 4hr, 6hr, 12hr and 16hr postdose. Sampling for PK analysis will occur predose on Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25 (within 30 minutes before dosing). Sampling for PK analysis will occur at 24hr, 36 hr, 48 hr, 52, 72 hr and 96hr, 120hr and 144hr post Day 28 dose. Sampling for PK analysis will occur at EOS/ Day 35..

Eligibility
Key inclusion criteria
• Male or female, age 18 to 55 years
• Females must be either postmenopausal for equal to 1 year (or with follicle-stimulating hormone (FSH) equals to 40 mIU/mL if postmenopausal for less than 1 year) or surgically sterile
• Males with female partners of childbearing potential must agree to use a barrier contraceptive (i.e., condom) and their female partners must use a highly effective method of contraception from Screening through 90 days after the last dose of study drug. Males must also 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.
• Nonsmoker, ex-smoker, or light smoker who smokes less than 5 cigarettes per week and has a negative urine cotinine test at screening.
• Body mass index between 18 and 32 kg/m2, inclusive.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• The subject has had surgery or trauma with significant blood loss within the last 3 months prior to the first dose of study drug.
• The subject has donated more than 1 unit (500 mL) of blood with 4 weeks prior to the first dose of study drug.
• Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening
• 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
• Consumed food or drink containing grapefruit juice within 72 hours before start of dosing unless approved by the investigator and sponsor.
• Consumed alcohol within 72 hours before start of dosing.
• The subject has taken prescription medications within 14 days (or within 5 half-lives, whichever is longer) or nonprescription medication, herbal remedies, vitamins or minerals within 7 days prior to the administration of the first dose of study, unless otherwise approved by the investigator and sponsor.
• The subject exercises extensively (e.g. marathon, triathlon or other similar high energetic sports). In general, subjects should refrain from sporting from 4 days before participation in the study until the EOS/ET visit.

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. Unblinded pharmacy (or other qualified site) personnel will be utilized to prepare the study drug for this trial.

Subjects will receive a 3-digit screening number at the Screening Visit following informed consent and if deemed eligible, a randomization number will be allocated (based on the randomization schedule) at any time from Day -1 to prior to dosing on Day 1. The assignment of number and code for subject identification is based on the obligation for anonymity.
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 an unblinded Statistician and provided to the site prior to study commencement.
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
Pharmacokinetics
Statistical methods / analysis
Plasma samples from subjects in the PK Analysis Population will be analyzed for the concentration of prodrug FP-045 and active metabolite AD-835. The plasma PK parameters of prodrug FP 045 (and active metabolite AD-835) will be determined based upon the prodrug FP-045 and active metabolite AD 835 concentrations, respectively. Concentrations of prodrug FP-045 and active metabolite AD-835 and PK parameters will be summarized by FP-045 dose level and compared using graphics and descriptive statistics.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/08/2019
Actual
3/09/2019
Date of last participant enrolment
Anticipated
31/10/2019
Actual
14/10/2019
Date of last data collection
Anticipated
Actual
1/11/2019
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14014 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 26799 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 303076 0
Commercial sector/Industry
Name [1] 303076 0
Foresee Pharmaceuticals Co., Ltd.
Country [1] 303076 0
Taiwan, Province Of China
Primary sponsor type
Commercial sector/Industry
Name
Foresee Pharmaceuticals Co., Ltd.
Address
3F., No. 19-3, Sanchong Rd., NanKang District.
Taipei 115, Taiwan
Country
Taiwan, Province Of China
Secondary sponsor category [1] 303060 0
Commercial sector/Industry
Name [1] 303060 0
InClin Pty Ltd
Address [1] 303060 0
210 / 25 Berry Street
North Sydney, NSW
Australia, 2060
Country [1] 303060 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303624 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 303624 0
Old Baker Building, Level 1, 55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 303624 0
Australia
Date submitted for ethics approval [1] 303624 0
03/07/2019
Approval date [1] 303624 0
26/07/2019
Ethics approval number [1] 303624 0

Summary
Brief summary
The purpose of this study is to evaluate the safety and tolerability of 28 days of daily dosing of orally administered FP-045 400 mg into normal, healthy volunteers
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94302 0
Dr Jason Lickliter
Address 94302 0
The Nucleus Network Burnet Tower AMREP Precinct 89 Commercial Rd Melbourne VIC 3001
Country 94302 0
Australia
Phone 94302 0
+61 3 9076 8960
Fax 94302 0
Email 94302 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 94303 0
Mr Taylor Kilfoil
Address 94303 0
InClin Pty. Ltd.
210 / 25 Berry Street
North Sydney, NSW
Australia, 2060
Country 94303 0
Australia
Phone 94303 0
+61 408 880 403
Fax 94303 0
Email 94303 0
tkilfoil@inclin.com
Contact person for scientific queries
Name 94304 0
Dr Yisheng Lee
Address 94304 0
Foresee Pharmaceuticals Co., Ltd.
1 Innovation Way, Suite 100, Newark, DE 19711, USA
Country 94304 0
United States of America
Phone 94304 0
+1 408 823 4807
Fax 94304 0
Email 94304 0
Yisheng.Lee@foreseepharma.com

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo FP-045 was well tolerated. Daily dosing of FP-045 ... [More Details]

Documents added automatically
No additional documents have been identified.