Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 8 for:    FDL169 | Cystic Fibrosis

Pharmacokinetics of FDL169 in Healthy Female Subjects

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: 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

Brief Summary:
To determine the pharmacokinetics of single and multiple doses of FDL169 in healthy female subjects.

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

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase I Dose Escalation Study to Assess the Pharmacokinetics (PK) of FDL169 in Healthy Female Volunteers
Study Start Date : December 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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: Multiple dose
Repeat doses of FDL169 to be administered at a dose level to be determined
Drug: FDL169



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. 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 ]
  13. 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 ]
  14. 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 ]
  15. 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 ]
  16. 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 ]
  17. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02680418


Locations
Layout table for location information
United Kingdom
Simbec Research Ltd
Merthyr Tydfil, Wales, United Kingdom, CF48 4DR
Sponsors and Collaborators
Flatley Discovery Lab LLC
Investigators
Layout table for investigator information
Principal Investigator: Khalid Abou-Farha, MBChB MD PhD Simbec Research

Layout table for additonal information
Responsible Party: Flatley Discovery Lab LLC
ClinicalTrials.gov Identifier: NCT02680418     History of Changes
Other Study ID Numbers: FDL169-2015-02
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases