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

NCT02359357 | Completed Phase 1

• 2 other identifiers: FDL169-2014-01RD 674/25728
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (4)

• Part 1A: safety and tolerability for 48 h following single oral doses of FDL169 (Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs)

  Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs)

  Multiple points from screening to follow-up (up to 28 days)

• Part 1B: food effect on the tolerability of FDL169 for 48 h following a single dose

  Vital signs, ECG, safety laboratory data and AEs

  Multiple points from screening to follow-up (up to 42 days)

• Part 2: safety and tolerability following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose) (Vital signs, ECG, safety laboratory data and AEs)

  Vital signs, ECG, safety laboratory data and AEs

  Multiple points from screening to follow-up (up to 42 days)

• Part 1B: food effect on the pharmacokinetics of FDL169 for 48 h following a single dose

  Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated

  Multiple points from pre-dose to 48 h post-dose

Secondary Outcomes (2)

• Part 1: pharmacokinetic profile for 48 h following single oral doses of FDL169

  Multiple points from pre-dose to 48 h post-dose

• Part 2: pharmacokinetic profile following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose)

  Multiple points from pre-dose to 24 h post-dosing on Day 14

Study Arms (22)

Placebo single dose

PLACEBO COMPARATOR

Placebo administered as a single dose

Drug: Placebo

Single dose (Dose level 1)

EXPERIMENTAL

FDL169 (Dose level 1) administered as a single dose

Drug: FDL169

Single dose (Dose level 2)

EXPERIMENTAL

FDL169 (Dose level 2) administered as a single dose

Drug: FDL169

Single dose (Dose level 3)

EXPERIMENTAL

FDL169 (Dose level 3) administered as a single dose

Drug: FDL169

Single dose (Dose level 4)

EXPERIMENTAL

FDL169 (Dose level 4) administered as a single dose

Drug: FDL169

Single dose (Dose level 5)

EXPERIMENTAL

FDL169 (Dose level 5) administered as a single dose

Drug: FDL169

Single dose (Dose level 6)

EXPERIMENTAL

FDL169 (Dose level 6) administered as a single dose

Drug: FDL169

Single dose (Dose level 7)

EXPERIMENTAL

FDL169 (Dose level 7) administered as a single dose

Drug: FDL169

Single dose (Dose level 8)

EXPERIMENTAL

FDL169 (Dose level 8) administered as a single dose

Drug: FDL169

Additional single dose 1

EXPERIMENTAL

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

Drug: FDL169

Additional single dose 2

EXPERIMENTAL

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

Drug: FDL169

Additional single dose 3

EXPERIMENTAL

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

Drug: FDL169

Additional single dose 4

EXPERIMENTAL

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

Drug: FDL169

Food effect - fasted

EXPERIMENTAL

Single dose of FDL169 in fasted conditions

Drug: FDL169

Food effect - fed

EXPERIMENTAL

Single dose of FDL169 in fed conditions

Drug: FDL169

Placebo - multiple dose

PLACEBO COMPARATOR

Repeat doses of placebo

Drug: Placebo

Multiple dose - Dose level 1

EXPERIMENTAL

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

Drug: FDL169

Multiple dose - Dose level 2

EXPERIMENTAL

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

Drug: FDL169

Multiple dose - Dose level 3

EXPERIMENTAL

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

Drug: FDL169

Multiple dose - Dose level 4

EXPERIMENTAL

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

Drug: FDL169

Multiple dose - additional dose level 1

EXPERIMENTAL

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

Drug: FDL169

Multiple dose - additional dose level 2

EXPERIMENTAL

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

Drug: FDL169

Interventions

FDL169 DRUG

Additional single dose 1; Additional single dose 2; Additional single dose 3; Additional single dose 4; Food effect - fasted; Food effect - fed; Multiple dose - Dose level 1; Multiple dose - Dose level 2; Multiple dose - Dose level 3; Multiple dose - Dose level 4; Multiple dose - additional dose level 1; Multiple dose - additional dose level 2; Single dose (Dose level 1); Single dose (Dose level 2); Single dose (Dose level 3); Single dose (Dose level 4); Single dose (Dose level 5); Single dose (Dose level 6); Single dose (Dose level 7); Single dose (Dose level 8)

Placebo DRUG

Placebo - multiple dose; Placebo single dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Flatley Discovery Lab LLC: lead

Study Sites (1)

Simbec Research Ltd

Merthyr Tydfil, Wales, CF48 4DR, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Salvatore Febbraro, MD

  Simbec Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: February 10, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 8, 2016

Record last verified: 2016-04

Locations

GB (1)