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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03516331
• Date of registration: 24/04/2018
• Prospective Registration: No
• Primary sponsor: Flatley Discovery Lab LLC
• Public title: A Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects
• Scientific title: A Phase 1, Open Label, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects
• Date of first enrolment: March 7, 2018
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03516331
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Claudia Ordonez, MD
• Affiliation: Flatley Discovery Lab

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: FDL176 & FDL169 coadministration

Primary Outcome(s)

Pharmacokinetic parameters, Cmax [Time Frame: 72 days]

Secondary Outcome(s)

Incidence of Treatment-Emergent Adverse Events [Time Frame: 72 days]

Secondary ID(s)

FDL169-2017-07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors