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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03527095

Enrollment

Registered

2018-05-16

Start date

2018-04-05

Completion date

2018-06-21

Last updated

2018-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis

Brief summary

This is a randomised, cross-over study comprised of 6 periods in healthy subjects.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable.

Detailed description

This is a single centre, randomised, cross-over study comprised of 6 periods in healthy males and females.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable.

Interventions

DRUGFDL169

CFTR corrector

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Relative bioavailability of FDL169 and its metabolites with different formulations	17 weeks	To determine the relative bioavailability of FDL169 and its metabolites M1 and M3, following different tablet formulations compared to a reference tablet

Secondary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events	17 weeks	Safety and tolerability of FDL169 and its metabolites M1 and M3 , as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s.
Pharmacokinetic parameters, Cmax	17 weeks	The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3 , maximal plasma concentration (Cmax)
Pharmacokinetic parameters, Tmax	17 weeks	The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; maximal concentration (Tmax)
Pharmacokinetic parameters, AUC	17 weeks	The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; area under the plasma concentration curve (AUC)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026