- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02359357
FTIH - Single and Repeat Oral Doses of FDL169 in Healthy Volunteers
A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation First-Time-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeat Oral Doses of FDL169 in Healthy Volunteers
Study Overview
Detailed Description
This study is the first time in human study and consists of two parts.
Part 1A:
Part 1 of the study is a randomised, double-blind, placebo-controlled, dose-escalation, first-time-in-human study to assess the safety, tolerability and PK profiles following single oral administrations of FDL169 to healthy male volunteers. Sixty-four (64) male subjects (8 per cohort) will be included in Part 1 of the study. Up to eight dose levels of FDL169 are planned to be tested in Part 1 of the study.
Part 1B:
Open label. Following completion of Part 1A of the study, an additional cohort of 8 subjects will receive a single dose of FDL169 in both fasted and fed states
Part 2:
Part 2 of the study is a randomised, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and PK profiles following multiple oral administrations of FDL169 to healthy male subjects. Forty-eight male subjects, in cohorts of twelve, will be included in Part 2 of the study. It is planned to test up to four dose levels of FDL169 in Part 2.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Wales
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Merthyr Tydfil, Wales, United Kingdom, CF48 4DR
- Simbec Research Ltd
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Healthy male subjects aged 18 to 45 years who fulfil standard safety screening assessments for the study (haematology/biochemistry, urinalysis, 12-lead electrocardiogram (ECG), vital signs and oral temperature) and who in the opinion of the Investigator, are medically suitable to participate in the study. Male subjects and their partners must be willing to use an effective method of contraception from first dose of investigational medicinal product (IMP) and for 3 months after the last dose of IMP.
Exclusion Criteria:
- Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months.
- Subjects who have history or presence of clinically significant cardiovascular, pulmonary, renal, hepatic, haematologic, gastrointestinal (endocrine or immunologic disease), at Screening.
- Donation of 500 mL or more blood within the previous 3 months.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 21 days (or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Flatley Discovery Labs Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- Smoking or use tobacco products or substitutes equivalent to > 15 cigarettes/day.
- Any subject attempting to father a child within 3 months of their Follow-Up Visit.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single dose (Dose level 1)
FDL169 (Dose level 1) administered as a single dose
|
|
Experimental: Single dose (Dose level 2)
FDL169 (Dose level 2) administered as a single dose
|
|
Experimental: Single dose (Dose level 3)
FDL169 (Dose level 3) administered as a single dose
|
|
Experimental: Single dose (Dose level 4)
FDL169 (Dose level 4) administered as a single dose
|
|
Experimental: Single dose (Dose level 5)
FDL169 (Dose level 5) administered as a single dose
|
|
Placebo Comparator: Placebo single dose
Placebo administered as a single dose
|
|
Experimental: Single dose (Dose level 6)
FDL169 (Dose level 6) administered as a single dose
|
|
Experimental: Single dose (Dose level 7)
FDL169 (Dose level 7) administered as a single dose
|
|
Experimental: Single dose (Dose level 8)
FDL169 (Dose level 8) administered as a single dose
|
|
Experimental: Additional single dose 1
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
|
|
Experimental: Additional single dose 2
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
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|
Experimental: Additional single dose 3
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
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|
Experimental: Additional single dose 4
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
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Experimental: Food effect - fasted
Single dose of FDL169 in fasted conditions
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Experimental: Food effect - fed
Single dose of FDL169 in fed conditions
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Placebo Comparator: Placebo - multiple dose
Repeat doses of placebo
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Experimental: Multiple dose - Dose level 1
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
|
|
Experimental: Multiple dose - Dose level 2
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
|
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Experimental: Multiple dose - Dose level 3
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
|
|
Experimental: Multiple dose - Dose level 4
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
|
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Experimental: Multiple dose - additional dose level 1
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
|
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Experimental: Multiple dose - additional dose level 2
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1A: safety and tolerability for 48 h following single oral doses of FDL169 (Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs)
Time Frame: Multiple points from screening to follow-up (up to 28 days)
|
Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs)
|
Multiple points from screening to follow-up (up to 28 days)
|
Part 1B: food effect on the tolerability of FDL169 for 48 h following a single dose
Time Frame: Multiple points from screening to follow-up (up to 42 days)
|
Vital signs, ECG, safety laboratory data and AEs
|
Multiple points from screening to follow-up (up to 42 days)
|
Part 2: safety and tolerability following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose) (Vital signs, ECG, safety laboratory data and AEs)
Time Frame: Multiple points from screening to follow-up (up to 42 days)
|
Vital signs, ECG, safety laboratory data and AEs
|
Multiple points from screening to follow-up (up to 42 days)
|
Part 1B: food effect on the pharmacokinetics of FDL169 for 48 h following a single dose
Time Frame: Multiple points from pre-dose to 48 h post-dose
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Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated
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Multiple points from pre-dose to 48 h post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1: pharmacokinetic profile for 48 h following single oral doses of FDL169
Time Frame: Multiple points from pre-dose to 48 h post-dose
|
Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated
|
Multiple points from pre-dose to 48 h post-dose
|
Part 2: pharmacokinetic profile following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose)
Time Frame: Multiple points from pre-dose to 24 h post-dosing on Day 14
|
Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated
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Multiple points from pre-dose to 24 h post-dosing on Day 14
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDL169-2014-01
- RD 674/25728 (Other Identifier: Sponsor)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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