Clinical trial NCT02359357: FTIH - Single and Repeat Oral Doses of FDL169 in Healthy Volunteers
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Flatley Discovery Lab LLC
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To determine the safety and tolerability of single and multiple escalating doses of FDL169 in healthy male subjects.

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.

Eligibility criteria: 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:

1. Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months.
2. Subjects who have history or presence of clinically significant cardiovascular, pulmonary, renal, hepatic, haematologic, gastrointestinal (endocrine or immunologic disease), at Screening.
3. Donation of 500 mL or more blood within the previous 3 months.
4. 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.
5. Smoking or use tobacco products or substitutes equivalent to \> 15 cigarettes/day.
6. Any subject attempting to father a child within 3 months of their Follow-Up Visit.

Primary outcomes:
measure: 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)
timeFrame: Multiple points from screening to follow-up (up to 28 days)
measure: Part 1B: food effect on the tolerability of FDL169 for 48 h following a single dose
timeFrame: Multiple points from screening to follow-up (up to 42 days)
measure: 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)
timeFrame: Multiple points from screening to follow-up (up to 42 days)
measure: Part 1B: food effect on the pharmacokinetics of FDL169 for 48 h following a single dose
timeFrame: Multiple points from pre-dose to 48 h post-dose
Secondary outcomes:
measure: Part 1: pharmacokinetic profile for 48 h following single oral doses of FDL169
timeFrame: Multiple points from pre-dose to 48 h post-dose
measure: Part 2: pharmacokinetic profile following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose)
timeFrame: Multiple points from pre-dose to 24 h post-dosing on Day 14
Other outcomes:
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Simbec Research Ltd
state: Wales
Study officials:
affiliation: Simbec Research
name: Salvatore Febbraro, MD
role: PRINCIPAL_INVESTIGATOR
References: