FTIH - Single and Repeat Oral Doses of FDL169 in Healthy Volunteers

Flatley Discovery Lab

Status and phase: Completed; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: FDL169; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02359357

FDL169-2014-01

RD 674/25728 (Other Identifier)

Details and patient eligibility

About

To determine the safety and tolerability of single and multiple escalating doses of FDL169 in healthy male subjects.

Full description

This study is the first time in human study and consists of two parts.

Part 1A:

Part 1 of the study is a randomised, double-blind, placebo-controlled, dose-escalation, first-time-in-human study to assess the safety, tolerability and PK profiles following single oral administrations of FDL169 to healthy male volunteers. Sixty-four (64) male subjects (8 per cohort) will be included in Part 1 of the study. Up to eight dose levels of FDL169 are planned to be tested in Part 1 of the study.

Part 1B:

Open label. Following completion of Part 1A of the study, an additional cohort of 8 subjects will receive a single dose of FDL169 in both fasted and fed states

Part 2:

Part 2 of the study is a randomised, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and PK profiles following multiple oral administrations of FDL169 to healthy male subjects. Forty-eight male subjects, in cohorts of twelve, will be included in Part 2 of the study. It is planned to test up to four dose levels of FDL169 in Part 2.

Enrollment: 130 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects aged 18 to 45 years who fulfil standard safety screening assessments for the study (haematology/biochemistry, urinalysis, 12-lead electrocardiogram (ECG), vital signs and oral temperature) and who in the opinion of the Investigator, are medically suitable to participate in the study. Male subjects and their partners 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.

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 history or presence of clinically significant cardiovascular, pulmonary, renal, hepatic, haematologic, gastrointestinal (endocrine or immunologic disease), at Screening.
3. Donation of 500 mL or more blood within the previous 3 months.
4. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 21 days (or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Flatley Discovery Labs Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
5. Smoking or use tobacco products or substitutes equivalent to > 15 cigarettes/day.
6. Any subject attempting to father a child within 3 months of their Follow-Up Visit.

Trial design

130 participants in 22 patient groups, including a placebo group

Placebo single dose

Placebo Comparator group

Description:

Placebo administered as a single dose

Treatment:

Drug: Placebo

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

Single dose (Dose level 6)

Experimental group

Description:

FDL169 (Dose level 6) administered as a single dose

Treatment:

Drug: FDL169

Single dose (Dose level 7)

Experimental group

Description:

FDL169 (Dose level 7) administered as a single dose

Treatment:

Drug: FDL169

Single dose (Dose level 8)

Experimental group

Description:

FDL169 (Dose level 8) administered as a single dose

Treatment:

Drug: FDL169

Additional single dose 1

Experimental group

Description:

Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)

Treatment:

Drug: FDL169

Additional single dose 2

Experimental group

Description:

Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)

Treatment:

Drug: FDL169

Additional single dose 3

Experimental group

Description:

Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)

Treatment:

Drug: FDL169

Additional single dose 4

Experimental group

Description:

Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)

Treatment:

Drug: FDL169

Food effect - fasted

Experimental group

Description:

Single dose of FDL169 in fasted conditions

Treatment:

Drug: FDL169

Food effect - fed

Experimental group

Description:

Single dose of FDL169 in fed conditions

Treatment:

Drug: FDL169

Placebo - multiple dose

Placebo Comparator group

Description:

Repeat doses of placebo

Treatment:

Drug: Placebo

Multiple dose - Dose level 1

Experimental group

Description:

Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)

Treatment:

Drug: FDL169

Multiple dose - Dose level 2

Experimental group

Description:

Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)

Treatment:

Drug: FDL169

Multiple dose - Dose level 3

Experimental group

Description:

Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)

Treatment:

Drug: FDL169

Multiple dose - Dose level 4

Experimental group

Description:

Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)

Treatment:

Drug: FDL169

Multiple dose - additional dose level 1

Experimental group

Description:

Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)

Treatment:

Drug: FDL169

Multiple dose - additional dose level 2

Experimental group

Description:

Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)

Treatment:

Drug: FDL169