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Pharmacokinetics of FDL169 in Healthy Female Subjects

NCT ID: NCT02680418

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-02-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Single dose (Dose level 1)

FDL169 (Dose level 1) administered as a single dose

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Single dose (Dose level 2)

FDL169 (Dose level 2) administered as a single dose

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Single dose (Dose level 3)

FDL169 (Dose level 3) administered as a single dose

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Single dose (Dose level 4)

FDL169 (Dose level 4) administered as a single dose

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Single dose (Dose level 5)

FDL169 (Dose level 5) administered as a single dose

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Multiple dose

Repeat doses of FDL169 to be administered at a dose level to be determined

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Interventions

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FDL169

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Flatley Discovery Lab LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Khalid Abou-Farha, MBChB MD PhD

Role: PRINCIPAL_INVESTIGATOR

Simbec Research

Locations

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Simbec Research Ltd

Merthyr Tydfil, Wales, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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FDL169-2015-02

Identifier Type: -

Identifier Source: org_study_id