NCT03527095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2018

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2018

Completed
Last Updated

November 2, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

May 4, 2018

Last Update Submit

November 1, 2018

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Incidence of Treatment-Emergent Adverse Events

    17 weeks

  • Pharmacokinetic parameters, Cmax

    17 weeks

  • Pharmacokinetic parameters, Tmax

    17 weeks

  • Pharmacokinetic parameters, AUC

    17 weeks

Study Arms (6)

Regimen A

EXPERIMENTAL

FDL169 200 mg reference tablet

Drug: FDL169

Regimen B

EXPERIMENTAL

FDL169 200 mg testing tablet 1

Drug: FDL169

Regimen C

EXPERIMENTAL

FDL169 200 mg testing tablet 2

Drug: FDL169

Regimen D

EXPERIMENTAL

FDL169 200 mg testing tablet 1 or 2 with high fat diet

Drug: FDL169

Regimen E

EXPERIMENTAL

FDL169 200 mg testing tablet 1 or 2, fasted

Drug: FDL169

Regimen F

EXPERIMENTAL

FDL169 200 mg testing tablet 1 or 2, with standard diet

Drug: FDL169

Interventions

FDL169DRUG

CFTR corrector

Regimen ARegimen BRegimen CRegimen DRegimen ERegimen F

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Claudia Ordonez

    Flatley Discovery Lab

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 16, 2018

Study Start

April 5, 2018

Primary Completion

June 21, 2018

Study Completion

June 21, 2018

Last Updated

November 2, 2018

Record last verified: 2018-11

Locations

GB(1)