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

Cystic Fibrosis Clinical Trial

Official title:

A Phase 1, Open Label, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516331
• Other study ID #: FDL169-2017-07
• Status: Completed
• Phase: Phase 1
• Start date: March 7, 2018
• Est. completion date: August 22, 2018

Study information

• Verified date: November 2018
• Source: Flatley Discovery Lab LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Description:

This is an open-label, non-randomised, single-sequence 2-part study. Enrolment into Part 2 of the study will begin after Part 1 is complete, and a review of safety and pharmacokinetic data has been completed.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 once daily (QD) with and without co-administration of FDL169.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 22, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• FDL176 & FDL169 coadministration
CFTR corrector and potentiator

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Nottingham	Ruddington

Sponsors (1)

Lead Sponsor	Collaborator
Flatley Discovery Lab LLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Treatment-Emergent Adverse Events	Safety and tolerability of FDL176 when co-administered with FDL169, compared to FDL176 alone. as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s.	72 days