A DDI Study of FDL169 and FDL176 in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03756922
• Date of registration: 27/11/2018
• Prospective Registration: Yes
• Primary sponsor: Flatley Discovery Lab LLC
• Public title: A DDI Study of FDL169 and FDL176 in Healthy Subjects
• Scientific title: A Phase 1/2, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects and in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR Mutation
• Date of first enrolment: November 27, 2018
• Target sample size: 78
• Recruitment status: Suspended
• URL: https://clinicaltrials.gov/show/NCT03756922
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

United Kingdom

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.

- 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 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 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.

- Consumption of any food or drink containing grapefruit, or Seville oranges (including
marmalade and fruit juices) for 14 days before the first dose of IMP.

- Consumptions or foods containing poppy seeds or involvement in strenuous exercise for
3 days before admission.

- Known hypersensitivity to any component of the formulation of FDL169 or FDL176.

- Pregnant or nursing females.

- History of regular alcohol consumption within 6 months of the study

- Current smoking or use of tobacco products or substitutes.

- Poor peripheral venous access.

- Donation of =470 mL blood or loss of blood during surgery or due to trauma within 3
months prior to Day 1.

- Plasma donation within 7 days prior to Day 1.

- Failure to satisfy the Investigator of their fitness to participate for any other
reason.

- Site staff, Sponsor staff or first degree family members of site or Sponsor.



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

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: FDL176

Drug: FDL169

Primary Outcome(s)

Pharmacokinetic parameters, Cmax [Time Frame: Part 1: 14 weeks; Part 2: 12 weeks; Part 3: 12weeks; Part 4: 12 weeks]

Secondary Outcome(s)

Incidence of Treatment-Emergent Adverse Events [Time Frame: Part 1: 14 weeks; Part 2: 12 weeks; Part 3: 12weeks; Part 4: 12 weeks]

Secondary ID(s)

FDL169-2018-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors