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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	31 October 2016
Main ID:	NCT02767297
Date of registration:	05/05/2016
Prospective Registration:	No
Primary sponsor:	Flatley Discovery Lab LLC
Public title:	Bioavailability and Pharmacokinetics Study of FDL169 in Healthy Subjects and Subjects With Cystic Fibrosis
Scientific title:	A Three-Part Phase 1b Bioavailability and Pharmacokinetics Study of Two Formulations of FDL169 in Healthy Subjects and Subjects With Cystic Fibrosis
Date of first enrolment:	April 2016
Target sample size:	46
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02767297
Study type:	Interventional
Study design:	Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Phase:	Phase 1/Phase 2

Countries of recruitment
United Kingdom

Contacts

Name:	Stuart Elborn, MD
Address:
Telephone:
Email:
Affiliation:	Queen's University

Key inclusion & exclusion criteria

Inclusion Criteria:

Parts 1 and 2:

1. Healthy, males and females between 18 and 55 years of age, inclusive, with a BMI of
>19 and <30 kg/m2.

2. If sexually active, must meet the contraception requirements.

Part 3:

1. Male and female subjects aged 18 years and older.

2. If sexually active, must meet the contraception requirements.

3. Diagnosis of CF.

4. History of pancreatic insufficiency.

5. Forced expiratory volume in 1 second (FEV1) =40% of predicted normal for age, sex and
height at screening.

Exclusion Criteria:

Parts 1 and 2:

1. Prior or ongoing medical condition, medical history, physical findings, ECG findings
or laboratory abnormality that could adversely affect the safety of the subject.

2. Alkaline phosphatase, aspartate aminotransferase (AST) and/or alanine
aminotransferase (ALT) level >1.5 x upper limit of normal (ULN) at screening.

3. Use of prescription or non-prescription drugs within 21 days or five half-lives
(whichever is longer) before the first dose of study medication, unless the
medication will not interfere with the study procedures or compromise subject safety.

4. Pregnant or nursing females.

5. Serum creatinine or total bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is
acceptable if bilirubin is fractionated and direct bilirubin is <35%).

6. History of prolonged QT and/or QTcF interval.

7. ECG with a single QTcF >450 msec in males, >460 msec in females, at Screening.

8. Positive urinary drugs of abuse screen at Screening or Day -1, or positive alcohol
screen at Day -1.

9. History of regular alcohol consumption within 6 months of the study defined as an
average weekly intake of >21 units.

10. History of human immunodeficiency virus (HIV) or positive HIV, hepatitis B or
hepatitis C results at screening.

11. Donation of 500 mL or more blood within 3 months before Day -1.

12. Participation in a clinical trial involving receipt of an investigational product
within the past 90 days or exposure to more than four new chemical entities with 12
months of the first dosing day.

13. Current smoking or use of tobacco products or substitutes. Former smokers will be
eligible, provided they have not smoked for at least 6 months before Day -1.

14. Use of any prescription and non-prescription medications that are inhibitors or
inducers of cytochrome P450 (CYP) 3A4 within 7 days before Day -1.

Part 3:

1. History of any illness, or ongoing acute illness that could impact the safety of the
subject or confound study results.

2. Abnormal liver function =3 x ULN: AST, ALT, total bilirubin.

3. A pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks
prior to the Baseline (Day 1) Visit

4. Use of herbal and dietary supplements within 21 days or five half-lives (whichever is
longer) before the first dose of study medication, unless the medication will not
interfere with the study procedures or compromise subject safety.

5. Pregnant or nursing females.

6. Serum creatinine or total bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is
acceptable if bilirubin is fractionated and direct bilirubin is <35%).

7. History of prolonged QT and/or QTcF interval.

8. ECG with a single QTcF >450 msec in males, >460 msec in females, at Screening.

9. Positive urinary drugs of abuse screen at Screening or Day -1, or positive alcohol
screen at Day -1.

10. History of regular alcohol consumption within 6 months of the study defined as an
average weekly intake of >21 units.

11. History of HIV, or positive HIV, hepatitis B or hepatitis C results at screening.

12. Donation of 500 mL or more blood within 3 months before Day -1.

13. Participation in a clinical trial involving receipt of an investigational product
within the past 90 days or exposure to more than four new chemical entities with 12
months of the first dosing day.

14. Current smoking or use of tobacco products or substitutes. Former smokers will be
eligible, provided they have not smoked for at least 6 months before Day -1.

15. Use of any prescription and non-prescription medications that are inhibitors or
inducers of CYP3A4, within 7 days before Day -1.

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: FDL169

Primary Outcome(s)

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 [Time Frame: Multiple points from pre-dose to 48 h post last 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 FDL169 [Time Frame: Multiple points from pre-dose to 48 h post last dose]

Part 3: Clearance of FDL169 (and metabolites) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 48 h post-dose]

Part 1: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 72 h post-dose]

Part 1: Maximum plasma concentration of FDL169 (and metabolites) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 72 h post-dose]

Part 3: Maximum plasma concentration of FDL169 (and metabolites) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 48 h post-dose]

Part 2: AUC% extrapolated for FDL169 (and metabolites) following multiple oral doses of FDL169 [Time Frame: Multiple points from pre-dose to 48 h post last dose]

Part 2: Terminal half-life of FDL169 (and metabolites) following multiple oral doses of FDL169 [Time Frame: Multiple points from pre-dose to 48 h post last dose]

Part 3: Time to maximum plasma concentration of FDL169 (and metabolites) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 48 h post-dose]

Part 1: AUC% extrapolated for FDL169 (and metabolites) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 72 h post-dose]

Part 1: Terminal half-life of FDL169 (and metabolites) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 72 h post-dose]

Part 1: Clearance of FDL169 (and metabolites) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 72 h post-dose]

Part 3: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) following single oral dose 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) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 72 h post-dose]

Part 3: Terminal half-life of FDL169 (and metabolites) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 48 h post-dose]

Part 3: AUC extrapolated to infinity from dosing time, based on the last observed concentration for FDL169 (and metabolites) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 48 h post-dose]

Part 1: AUC extrapolated to infinity from dosing time, based on the last observed concentration for FDL169 (and metabolites) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 72 h post-dose]

Part 1: AUC from the time of dosing to the time of the last observed concentration for FDL169 (and metabolites) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 72 h post-dose]

Part 3: AUC% extrapolated for FDL169 (and metabolites) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 48 h post-dose]

Part 2: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) following multiple oral doses of FDL169 [Time Frame: Multiple points from pre-dose to 48 h post last dose]

Part 2: Maximum plasma concentration of FDL169 (and metabolites) following multiple oral doses of FDL169 [Time Frame: Multiple points from pre-dose to 48 h post last dose]

Part 2: Clearance of FDL169 (and metabolites) following multiple oral doses of FDL169 [Time Frame: Multiple points from pre-dose to 48 h post last dose]

Part 3: AUC from the time of dosing to the time of the last observed concentration for FDL169 (and metabolites) following single oral dose of FDL169 [Time Frame: Multiple points from pre-dose to 48 h post-dose]

Part 2: Time to maximum plasma concentration of FDL169 (and metabolites) following multiple oral doses of FDL169 [Time Frame: Multiple points from pre-dose to 48 h post last dose]

Secondary Outcome(s)

Number of subjects with clinically significant changes in oral temperature following single and multiple oral doses of FDL169 [Time Frame: Multiple points from screening to follow-up (7 days after last dose)]

Number of subjects with clinically significant changes in heart rate following single and multiple oral doses of FDL169 [Time Frame: Multiple points from screening to follow-up (7 days after last dose)]

Number of subjects with clinically significant 12-lead ECG abnormalities following single and multiple oral doses of FDL169 [Time Frame: Multiple points from screening to follow-up (7 days after last dose)]

Number of subjects experiencing treatment-related adverse events following single and multiple oral doses of FDL169 [Time Frame: Multiple points from screening to follow-up (7 days after last dose)]

Number of subjects with abnormal laboratory values following single and multiple oral doses of FDL169 [Time Frame: Multiple points from screening to follow-up (7 days after last dose)]

Number of subjects with clinically significant changes in oxygen saturation following single and multiple oral doses of FDL169 [Time Frame: Multiple points from screening to follow-up (7 days after last dose)]

Number of subjects with clinically significant changes in systolic and diastolic blood pressure following single and multiple oral doses of FDL169 [Time Frame: Multiple points from screening to follow-up (7 days after last dose)]

Secondary ID(s)

FDL169-2015-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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