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

Cystic Fibrosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527095
• Other study ID #: FDL169-2017-06
• Status: Completed
• Phase: Phase 1
• Start date: April 5, 2018
• Est. completion date: June 21, 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 21, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• FDL169
CFTR corrector

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Ruddington	Nottingham

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	Relative bioavailability of FDL169 and its metabolites with different formulations	To determine the relative bioavailability of FDL169 and its metabolites M1 and M3, following different tablet formulations compared to a reference tablet	17 weeks
Secondary	Incidence of Treatment-Emergent Adverse Events	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.	17 weeks
Secondary	Pharmacokinetic parameters, Cmax	The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3 , maximal plasma concentration (Cmax)	17 weeks
Secondary	Pharmacokinetic parameters, Tmax	The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; maximal concentration (Tmax)	17 weeks
Secondary	Pharmacokinetic parameters, AUC	The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; area under the plasma concentration curve (AUC)	17 weeks