Pharmacokinetics of FDL169 in Healthy Female Subjects

Flatley Discovery Lab

Status and phase: Completed; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: FDL169

Study type: Interventional

Funder types: Other

Identifiers

NCT02680418

FDL169-2015-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

8 participants in 6 patient groups

Single dose (Dose level 1)

Experimental group

Description:

FDL169 (Dose level 1) administered as a single dose

Treatment:

Drug: FDL169

Single dose (Dose level 2)

Experimental group

Description:

FDL169 (Dose level 2) administered as a single dose

Treatment:

Drug: FDL169

Single dose (Dose level 3)

Experimental group

Description:

FDL169 (Dose level 3) administered as a single dose

Treatment:

Drug: FDL169

Single dose (Dose level 4)

Experimental group

Description:

FDL169 (Dose level 4) administered as a single dose

Treatment:

Drug: FDL169

Single dose (Dose level 5)

Experimental group

Description:

FDL169 (Dose level 5) administered as a single dose

Treatment:

Drug: FDL169

Multiple dose

Experimental group

Description:

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

Treatment:

Drug: FDL169