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Trial record 8 of 8 for:    FDL169 | Cystic Fibrosis

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

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ClinicalTrials.gov Identifier: NCT02359357
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Flatley Discovery Lab LLC

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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: FDL169 Drug: Placebo Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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 Start Date : January 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo single dose
Placebo administered as a single dose
Drug: Placebo
Experimental: Single dose (Dose level 1)
FDL169 (Dose level 1) administered as a single dose
Drug: FDL169
Experimental: Single dose (Dose level 2)
FDL169 (Dose level 2) administered as a single dose
Drug: FDL169
Experimental: Single dose (Dose level 3)
FDL169 (Dose level 3) administered as a single dose
Drug: FDL169
Experimental: Single dose (Dose level 4)
FDL169 (Dose level 4) administered as a single dose
Drug: FDL169
Experimental: Single dose (Dose level 5)
FDL169 (Dose level 5) administered as a single dose
Drug: FDL169
Experimental: Single dose (Dose level 6)
FDL169 (Dose level 6) administered as a single dose
Drug: FDL169
Experimental: Single dose (Dose level 7)
FDL169 (Dose level 7) administered as a single dose
Drug: FDL169
Experimental: Single dose (Dose level 8)
FDL169 (Dose level 8) administered as a single dose
Drug: FDL169
Experimental: Additional single dose 1
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
Drug: FDL169
Experimental: Additional single dose 2
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
Drug: FDL169
Experimental: Additional single dose 3
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
Drug: FDL169
Experimental: Additional single dose 4
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
Drug: FDL169
Experimental: Food effect - fasted
Single dose of FDL169 in fasted conditions
Drug: FDL169
Experimental: Food effect - fed
Single dose of FDL169 in fed conditions
Drug: FDL169
Placebo Comparator: Placebo - multiple dose
Repeat doses of placebo
Drug: Placebo
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)
Drug: FDL169
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)
Drug: FDL169
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)
Drug: FDL169
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)
Drug: FDL169
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)
Drug: FDL169
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)
Drug: FDL169



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359357


Locations
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United Kingdom
Simbec Research Ltd
Merthyr Tydfil, Wales, United Kingdom, CF48 4DR
Sponsors and Collaborators
Flatley Discovery Lab LLC
Investigators
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Principal Investigator: Salvatore Febbraro, MD Simbec Research

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Responsible Party: Flatley Discovery Lab LLC
ClinicalTrials.gov Identifier: NCT02359357     History of Changes
Other Study ID Numbers: FDL169-2014-01
RD 674/25728 ( Other Identifier: Sponsor )
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases