FTIH - Single and Repeat Oral Doses of FDL169 in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 18 April 2016
• Main ID: NCT02359357
• Date of registration: 13/01/2015
• Prospective Registration: No
• Primary sponsor: Flatley Discovery Lab LLC
• Public title: FTIH - Single and Repeat Oral Doses of FDL169 in Healthy Volunteers
• Scientific 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
• Date of first enrolment: January 2015
• Target sample size: 130
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02359357
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Salvatore Febbraro, MD
• Affiliation: Simbec Research

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Placebo

Drug: FDL169

Primary Outcome(s)

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)]

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)]

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)]

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]

Secondary Outcome(s)

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]

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]

Secondary ID(s)

FDL169-2014-01

RD 674/25728

Source(s) of Monetary Support

Please refer to primary and secondary sponsors