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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359357
• Other study ID #: FDL169-2014-01
• Secondary ID: RD 674/25728
• Status: Completed
• Phase: Phase 1
• First received: January 13, 2015
• Last updated: April 7, 2016
• Start date: January 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Flatley Discovery Lab LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Drug:
• FDL169

• Placebo

Locations

Country	Name	City	State
United Kingdom	Simbec Research Ltd	Merthyr Tydfil	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Flatley Discovery Lab LLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs)	Multiple points from screening to follow-up (up to 28 days)	Yes
Primary	Part 1B: food effect on the tolerability of FDL169 for 48 h following a single dose	Vital signs, ECG, safety laboratory data and AEs	Multiple points from screening to follow-up (up to 42 days)	Yes
Primary	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)	Vital signs, ECG, safety laboratory data and AEs	Multiple points from screening to follow-up (up to 42 days)	Yes
Primary	Part 1B: food effect on the pharmacokinetics of FDL169 for 48 h following a single 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	No
Secondary	Part 1: pharmacokinetic profile for 48 h following single oral doses of FDL169	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	No
Secondary	Part 2: pharmacokinetic profile following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final 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 24 h post-dosing on Day 14	No