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Completed

NCT Number: NCT02359357

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

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

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Simbec Research Ltd

Merthyr Tydfil, Wales, CF48 4DR, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FDL169

Drug

Placebo

Drug

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

    Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Flatley Discovery Lab LLC

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2015
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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