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

NCT ID: NCT02359357

Last Updated: 2016-04-08

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

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo single dose

Placebo administered as a single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Single dose (Dose level 6)

FDL169 (Dose level 6) administered as a single dose

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Single dose (Dose level 7)

FDL169 (Dose level 7) administered as a single dose

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Single dose (Dose level 8)

FDL169 (Dose level 8) administered as a single dose

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Additional single dose 1

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

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Additional single dose 2

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

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Additional single dose 3

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

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Additional single dose 4

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

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Food effect - fasted

Single dose of FDL169 in fasted conditions

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Food effect - fed

Single dose of FDL169 in fed conditions

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Placebo - multiple dose

Repeat doses of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Multiple dose - Dose level 1

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

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Multiple dose - Dose level 2

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

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Multiple dose - Dose level 3

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

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Multiple dose - Dose level 4

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

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Multiple dose - additional dose level 1

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

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Multiple dose - additional dose level 2

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

Group Type EXPERIMENTAL

FDL169

Intervention Type DRUG

Interventions

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FDL169

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

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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Salvatore Febbraro, MD

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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RD 674/25728

Identifier Type: OTHER

Identifier Source: secondary_id

FDL169-2014-01

Identifier Type: -

Identifier Source: org_study_id

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