Title
FTIH - Single and Repeat Oral Doses of FDL169 in Healthy Volunteers
A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation First-Time-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeat Oral Doses of FDL169 in Healthy Volunteers
Phase
Phase 1Lead Sponsor
Flatley Discovery Lab LLCStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Cystic FibrosisIntervention/Treatment
fdl169 ...Study Participants
130To determine the safety and tolerability of single and multiple escalating doses of FDL169 in healthy male subjects.
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.
FDL169 (Dose level 1) administered as a single dose
FDL169 (Dose level 2) administered as a single dose
FDL169 (Dose level 3) administered as a single dose
FDL169 (Dose level 4) administered as a single dose
FDL169 (Dose level 5) administered as a single dose
FDL169 (Dose level 6) administered as a single dose
FDL169 (Dose level 7) administered as a single dose
FDL169 (Dose level 8) administered as a single dose
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
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: Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. Subjects who have history or presence of clinically significant cardiovascular, pulmonary, renal, hepatic, haematologic, gastrointestinal (endocrine or immunologic disease), at Screening. Donation of 500 mL or more blood within the previous 3 months. 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. Smoking or use tobacco products or substitutes equivalent to > 15 cigarettes/day. Any subject attempting to father a child within 3 months of their Follow-Up Visit.