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Trial record 7 of 8 for:    FDL169 | Cystic Fibrosis

Pharmacokinetics of FDL169 in Healthy Female Subjects

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ClinicalTrials.gov Identifier: NCT02680418
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
Flatley Discovery Lab LLC

Tracking Information
First Submitted Date  ICMJE February 2, 2016
First Posted Date  ICMJE February 11, 2016
Last Update Posted Date March 31, 2016
Study Start Date  ICMJE December 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
  • Part 1: Maximum plasma concentration of FDL169 (and metabolites) over 48 h following single oral doses of FDL169 [ Time Frame: Multiple points from pre-dose to 48 h post-dose ]
  • Part 1: Time to maximum plasma concentration of FDL169 (and metabolites) during 48 h following single oral doses of FDL169 [ Time Frame: Multiple points from pre-dose to 48 h post-dosing on Day 7 ]
  • Part 1: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) during 48 h following single oral doses of FDL169 [ Time Frame: Multiple points from pre-dose to 48 h post-dosing on Day 7 ]
  • Part 1: Terminal half-life of FDL169 (and metabolites) during 48 h following single oral doses of FDL169 [ Time Frame: Multiple points from pre-dose to 48 h post-dosing on Day 7 ]
  • Part 1: AUC from the time of dosing to the time of the last observed concentration for FDL169 (and metabolites) during 48 h following single oral doses of FDL169 [ Time Frame: Multiple points from pre-dose to 48 h post-dosing on Day 7 ]
  • Part 1: AUC extrapolated to infinity from dosing time, based on the last observed concentration for FDL169 (and metabolites) during 48 h following single oral doses of FDL169 [ Time Frame: Multiple points from pre-dose to 48 h post-dosing on Day 7 ]
  • Part 1: Clearance of FDL169 (and metabolites) during 48 h following single oral doses of FDL169 [ Time Frame: Multiple points from pre-dose to 48 h post-dosing on Day 7 ]
  • Part 1: AUC% extrapolated for FDL169 (and metabolites) during 48 h following single oral doses of FDL169 [ Time Frame: Multiple points from pre-dose to 48 h post-dosing on Day 7 ]
  • Part 2: Maximum plasma concentration of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose) [ Time Frame: Multiple points from pre-dose to 48 h post-final dose ]
  • Part 2: Time to maximum plasma concentration of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose) [ Time Frame: Multiple points from pre-dose to 48 h post-final dose ]
  • Part 2: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose) [ Time Frame: Multiple points from pre-dose to 48 h post-final dose ]
  • Part 2: Terminal half-life of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose) [ Time Frame: Multiple points from pre-dose to 48 h post-final dose ]
  • Part 2: AUC from the time of dosing to the time of the last observed concentration for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose) [ Time Frame: Multiple points from pre-dose to 48 h post-final dose ]
  • Part 2: AUC extrapolated to infinity from dosing time, based on the last observed concentration for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose) [ Time Frame: Multiple points from pre-dose to 48 h post-final dose ]
  • Part 2: AUC from the time of dosing to time t at steady state for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose) [ Time Frame: Multiple points from pre-dose to 48 h post-final dose ]
  • Part 2: Clearance of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose) [ Time Frame: Multiple points from pre-dose to 48 h post-final dose ]
  • Part 2: AUC% extrapolated for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose) [ Time Frame: Multiple points from pre-dose to 48 h post-final dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
  • Number of patients with clinically significant changes in systolic blood pressure following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose) [ Time Frame: Multiple points from pre-dose to 48 h post (last) dose ]
  • Number of patients with clinically significant changes in diastolic blood pressure following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose) [ Time Frame: Multiple points from pre-dose to 48 h post (last) dose ]
  • Number of patients with clinically significant changes in pulse rate following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose) [ Time Frame: Multiple points from pre-dose to 48 h post (last) dose ]
  • Number of patients with clinically significant changes in oxygen saturation following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose) [ Time Frame: Multiple points from pre-dose to 48 h post (last) dose ]
  • Number of patients with clinically significant changes in oral temperature following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose) [ Time Frame: Multiple points from pre-dose to 48 h post (last) dose ]
  • Number of patients with clinically significant 12-lead ECG abnormalities following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose) [ Time Frame: Multiple points from pre-dose to 48 h post (last) dose ]
  • Number of patients with abnormal laboratory values following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose) [ Time Frame: Multiple points from pre-dose to 48 h post (last) dose ]
  • Number of patients experiencing treatment-related adverse events following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose) [ Time Frame: Multiple points from pre-dose to 48 h post (last) dose ]
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 Pharmacokinetics of FDL169 in Healthy Female Subjects
Official Title  ICMJE A Phase I Dose Escalation Study to Assess the Pharmacokinetics (PK) of FDL169 in Healthy Female Volunteers
Brief Summary To determine the pharmacokinetics of single and multiple doses of FDL169 in healthy female subjects.
Detailed Description

This is a two-part study.

Part 1:

Part 1 of the study is a single-dose, dose-escalation, study to assess the safety, tolerability and PK profiles following oral administrations of FDL169 to healthy female volunteers in the fed state. Up to five doses will be assessed.

Part 2:

Part 2 of the study is a multiple-dose study to assess the safety, tolerability and PK profiles following oral administrations of FDL169 to healthy female volunteers in the fed state.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE Drug: FDL169
Study Arms  ICMJE
  • 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: Multiple dose
    Repeat doses of FDL169 to be administered at a dose level to be determined
    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: March 29, 2016)
8
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2016)
16
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy female subjects aged 18 to 55 years inclusive and of any ethnic origin with a body mass index (BMI) of > 19 and < 30 kg/m2. Body Mass Index = Body weight (kg) / [Height (m)]
  2. Subjects 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 (unless they are of non-child bearing potential).

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 any renal or clinically significant cardiac, renal or hepatic disease at Screening.
  3. Subjects who have history or presence of clinically significant cardiovascular, pulmonary, renal, hepatic, haematologic, gastrointestinal (with the exception of Gilbert's syndrome or asymptomatic gallstones), endocrine or immunologic disease at Screening.
  4. Have an abnormal twelve-lead ECG or an ECG with abnormality considered to be clinically significant in the opinion of the Investigator or an ECG with a single QTcB > 450 mSec.
  5. Subjects with a positive urinary drugs of abuse screen or positive alcohol screen at Screening or Day -1.
  6. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of > 21 units.
  7. Subject with history of HIV or positive human immunodeficiency virus, hepatitis B or hepatitis C results.
  8. Donation of 500 mL or more of blood within the previous 3 months.
  9. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and FDL Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  10. Smoking or use of tobacco products or substitutes equivalent to > 15 cigarettes/day.
  11. Any subject who is pregnant or nursing.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 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 NCT02680418
Other Study ID Numbers  ICMJE FDL169-2015-02
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: Khalid Abou-Farha, MBChB MD PhD Simbec Research
PRS Account Flatley Discovery Lab LLC
Verification Date March 2016

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