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Trial record 8 of 8 for:    FDL169 | Cystic Fibrosis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 13, 2015
First Posted Date  ICMJE February 10, 2015
Last Update Posted Date April 8, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2015)
  • 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)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2015)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FTIH - Single and Repeat Oral Doses of FDL169 in Healthy Volunteers
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE
  • Drug: FDL169
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo single dose
    Placebo administered as a single dose
    Intervention: Drug: Placebo
  • Experimental: Single dose (Dose level 1)
    FDL169 (Dose level 1) administered as a single dose
    Intervention: Drug: FDL169
  • Experimental: Single dose (Dose level 2)
    FDL169 (Dose level 2) administered as a single dose
    Intervention: Drug: FDL169
  • Experimental: Single dose (Dose level 3)
    FDL169 (Dose level 3) administered as a single dose
    Intervention: Drug: FDL169
  • Experimental: Single dose (Dose level 4)
    FDL169 (Dose level 4) administered as a single dose
    Intervention: Drug: FDL169
  • Experimental: Single dose (Dose level 5)
    FDL169 (Dose level 5) administered as a single dose
    Intervention: Drug: FDL169
  • Experimental: Single dose (Dose level 6)
    FDL169 (Dose level 6) administered as a single dose
    Intervention: Drug: FDL169
  • Experimental: Single dose (Dose level 7)
    FDL169 (Dose level 7) administered as a single dose
    Intervention: Drug: FDL169
  • Experimental: Single dose (Dose level 8)
    FDL169 (Dose level 8) administered as a single dose
    Intervention: 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)
    Intervention: 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)
    Intervention: 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)
    Intervention: 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)
    Intervention: Drug: FDL169
  • Experimental: Food effect - fasted
    Single dose of FDL169 in fasted conditions
    Intervention: Drug: FDL169
  • Experimental: Food effect - fed
    Single dose of FDL169 in fed conditions
    Intervention: Drug: FDL169
  • Placebo Comparator: Placebo - multiple dose
    Repeat doses of placebo
    Intervention: 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)
    Intervention: 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)
    Intervention: 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)
    Intervention: 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)
    Intervention: 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)
    Intervention: 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)
    Intervention: Drug: FDL169
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2016)
130
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2015)
176
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02359357
Other Study ID Numbers  ICMJE FDL169-2014-01
RD 674/25728 ( Other Identifier: Sponsor )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Flatley Discovery Lab LLC
Study Sponsor  ICMJE Flatley Discovery Lab LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Salvatore Febbraro, MD Simbec Research
PRS Account Flatley Discovery Lab LLC
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP