A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03527095
• Date of registration: 04/05/2018
• Prospective Registration: No
• Primary sponsor: Flatley Discovery Lab LLC
• Public title: A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects
• Scientific title: A Phase 1, Open-label, Randomised, Cross Over Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects Following Single Doses
• Date of first enrolment: April 5, 2018
• Target sample size: 11
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03527095
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Claudia Ordonez
• Affiliation: Flatley Discovery Lab

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male and non-pregnant, non-lactating female subjects

- Aged 18 to 55 years

- Body mass index of 18.0 to 32.0 kg/m2

- Must agree to the use of an adequate method of contraception

Exclusion Criteria:

- Subjects who have received any IMP in a clinical research study within the previous 3
months

- History of any drug or alcohol abuse in the past 2 years

- Current smokers and those who have smoked within the last 12 months.

- Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase level
>1.5 x upper limit of normal at screening

- Abnormal renal function at screening

- Clinically significant abnormal biochemistry, haematology, coagulation profile or
urinalysis

- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or
human immunodeficiency virus (HIV) results

- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory
or GI disease, neurological or psychiatric disorder.

- Subjects with a history of gall stones or abdominal surgery eg cholecystectomy

- Serious adverse reaction or serious hypersensitivity to any drug or the formulation
excipients

- Subjects who are taking, or have taken, any prescribed or over-the-counter drug or
herbal remedy (including known inhibitors or inducers of CYP3A4



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

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: FDL169

Primary Outcome(s)

Relative bioavailability of FDL169 and its metabolites with different formulations [Time Frame: 17 weeks]

Secondary Outcome(s)

Incidence of Treatment-Emergent Adverse Events [Time Frame: 17 weeks]

Pharmacokinetic parameters, Cmax [Time Frame: 17 weeks]

Pharmacokinetic parameters, AUC [Time Frame: 17 weeks]

Pharmacokinetic parameters, Tmax [Time Frame: 17 weeks]

Secondary ID(s)

FDL169-2017-06

Source(s) of Monetary Support

Please refer to primary and secondary sponsors