Pharmacokinetics of FDL169 in Healthy Female Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02680418
• Date of registration: 02/02/2016
• Prospective Registration: No
• Primary sponsor: Flatley Discovery Lab LLC
• Public title: Pharmacokinetics of FDL169 in Healthy Female Subjects
• Scientific title: A Phase I Dose Escalation Study to Assess the Pharmacokinetics (PK) of FDL169 in Healthy Female Volunteers
• Date of first enrolment: December 2015
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02680418
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Khalid Abou-Farha, MBChB MD PhD
• Affiliation: Simbec Research

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: FDL169

Primary Outcome(s)

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: 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: 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 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: 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 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: 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 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 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: 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]

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 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 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 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: 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]

Secondary Outcome(s)

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 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 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]

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 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 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 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]

Secondary ID(s)

FDL169-2015-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors