A Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects

NCT03516331 | Completed Phase 1 DMC

• 1 other identifier: FDL169-2017-07
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is an 2-part study. Part 1 will assess the safety, tolerability and pharmacokinetics of single doses of FDL176 with and without co-administration of FDL169. Part 2 will assess the safety, tolerability and pharmacokinetics of repeated doses of FDL176 with and without co-administration of FDL169 .

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters, Cmax

  The pharmacokinetic parameters of FDL176 when co-administered with FDL169, compared to the pharmacokinetics of FDL176 alone; maximal plasma concentration (Cmax)

  72 days

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  72 days

Study Arms (2)

Part 1:FDL176 & FDL169 coadministration

EXPERIMENTAL

To receive a single dose of FDL176 on Day 1, followed up FDL169 TID starting Day 8; and another single dose of FDL176 on Day 22.

Drug: FDL176 & FDL169 coadministration

Part 2:FDL176 & FDL169 coadministration

EXPERIMENTAL

To receive FDL176 QD starting Day 1, and FDL169 TID starting Day 8

Drug: FDL176 & FDL169 coadministration

Interventions

FDL176 & FDL169 coadministration DRUG

CFTR corrector and potentiator

Part 1:FDL176 & FDL169 coadministration; Part 2:FDL176 & FDL169 coadministration

Eligibility Criteria

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

You may qualify if:

• Healthy males or non-pregnant, non-lactating healthy females.
• Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator.
• Must agree to follow the study's contraception requirement

You may not qualify if:

• Prior or ongoing medical condition, medical history, physical findings, ECG findings or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the subject or would place the subject at increased risk.
• History of long QT syndrome and/or QT corrected according to Fridericia's formula (QTcF) interval (\>450 msec) or QTcF \>450 msec at Screening or Day -1.
• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active.
• Use of any prescription drugs within 14 days or 5 half-lives (whichever is longer) before the first dose of IMP, unless in the opinion of the Investigator (or delegate) .
• Use of any non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) before the first dose of IMP.
• Use of any prescription and non-prescription medications that are strong inhibitors or moderate inducers of cytochrome P450 3A, within 28 days before the first dose of IMP.
• Participation in another clinical trial involving receipt of an IMP within the past 90 days.
• Prior exposure to FDL169 or FDL176
• Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase \>1.5 x upper limit of normal (ULN) at screening.
• Serum creatinine or total bilirubin \>1.5 x ULN (isolated bilirubin \>1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \<35%).
• Abnormal renal function at screening, defined as estimated glomerular filtration rate \<60 mL/min using the Modification of Diet in Renal Disease (MDRD) equation.
• History of human immunodeficiency virus (HIV) or positive HIV, hepatitis B or hepatitis C results at screening.
• Positive urinary drugs of abuse screen at Screening or Day -1, or positive alcohol breath test at Screening or Day -1. Consumption of alcohol within 24 h prior to admission.

Sponsors & Collaborators

• Flatley Discovery Lab LLC: lead

Study Sites (1)

Quotient Sciences

Nottingham, Ruddington, NG11 6JS, 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

• Claudia Ordonez, MD

  Flatley Discovery Lab

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 4, 2018
• Study Start: March 7, 2018
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: November 2, 2018

Record last verified: 2018-11

Locations

GB (1)