Pharmacokinetics of FDL169 in Healthy Female Subjects

Flatley Discovery Lab LLC8 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

FDL169DRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Simbec Research Ltd

Merthyr Tydfil, Wales, United Kingdom

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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Secondary Outcomes

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)