Pharmacokinetics of FDL169 in Healthy Female Subjects

NCT02680418 | Completed Phase 1

• 1 other identifier: FDL169-2015-02
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (17)

• Part 1: Maximum plasma concentration of FDL169 (and metabolites) over 48 h following single oral doses of FDL169

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

• Part 1: Time to maximum plasma concentration of FDL169 (and metabolites) during 48 h following single oral doses of FDL169

  Multiple points from pre-dose to 48 h post-dosing on Day 7

• Part 1: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) during 48 h following single oral doses of FDL169

  Multiple points from pre-dose to 48 h post-dosing on Day 7

• Part 1: Terminal half-life of FDL169 (and metabolites) during 48 h following single oral doses of FDL169

  Multiple points from pre-dose to 48 h post-dosing on Day 7

• Part 1: AUC from the time of dosing to the time of the last observed concentration for FDL169 (and metabolites) during 48 h following single oral doses of FDL169

  Multiple points from pre-dose to 48 h post-dosing on Day 7

• Part 1: AUC extrapolated to infinity from dosing time, based on the last observed concentration for FDL169 (and metabolites) during 48 h following single oral doses of FDL169

  Multiple points from pre-dose to 48 h post-dosing on Day 7

• Part 1: Clearance of FDL169 (and metabolites) during 48 h following single oral doses of FDL169

  Multiple points from pre-dose to 48 h post-dosing on Day 7

• Part 1: AUC% extrapolated for FDL169 (and metabolites) during 48 h following single oral doses of FDL169

  Multiple points from pre-dose to 48 h post-dosing on Day 7

• Part 2: Maximum plasma concentration of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)

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

• Part 2: Time to maximum plasma concentration of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)

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

• Part 2: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)

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

• Part 2: Terminal half-life of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)

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

• Part 2: AUC from the time of dosing to the time of the last observed concentration for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)

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

• Part 2: AUC extrapolated to infinity from dosing time, based on the last observed concentration for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)

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

• Part 2: AUC from the time of dosing to time t at steady state for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)

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

• Part 2: Clearance of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)

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

• Part 2: AUC% extrapolated for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)

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

Secondary Outcomes (8)

• Number of patients with clinically significant changes in systolic blood pressure following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)

  Multiple points from pre-dose to 48 h post (last) dose

• Number of patients with clinically significant changes in diastolic blood pressure following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)

  Multiple points from pre-dose to 48 h post (last) dose

• Number of patients with clinically significant changes in pulse rate following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)

  Multiple points from pre-dose to 48 h post (last) dose

• Number of patients with clinically significant changes in oxygen saturation following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)

  Multiple points from pre-dose to 48 h post (last) dose

• Number of patients with clinically significant changes in oral temperature following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)

  Multiple points from pre-dose to 48 h post (last) dose

Study Arms (6)

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

Multiple dose

EXPERIMENTAL

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

Drug: FDL169

Interventions

FDL169 DRUG

Multiple dose; 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)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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) / \[Height (m)\]
• 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).

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 any renal or clinically significant cardiac, renal or hepatic disease at Screening.
• 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.
• 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.
• Subjects with a positive urinary drugs of abuse screen or positive alcohol screen at Screening or Day -1.
• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of \> 21 units.
• Subject with history of HIV or positive human immunodeficiency virus, hepatitis B or hepatitis C results.
• Donation of 500 mL or more of blood within the previous 3 months.
• 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.
• Smoking or use of tobacco products or substitutes equivalent to \> 15 cigarettes/day.
• Any subject who is pregnant or nursing.

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

• Khalid Abou-Farha, MBChB MD PhD

  Simbec Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 11, 2016
• Study Start: December 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

GB (1)