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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
FDL169
Sponsored by
Flatley Discovery Lab LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Quotient Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Regimen A

Regimen B

Regimen C

Regimen D

Regimen E

Regimen F

Arm Description

FDL169 200 mg reference tablet

FDL169 200 mg testing tablet 1

FDL169 200 mg testing tablet 2

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

FDL169 200 mg testing tablet 1 or 2, fasted

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Pharmacokinetic parameters, Cmax
The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3 , maximal plasma concentration (Cmax)
Pharmacokinetic parameters, Tmax
The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; maximal concentration (Tmax)
Pharmacokinetic parameters, AUC
The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; area under the plasma concentration curve (AUC)

Full Information

First Posted
May 4, 2018
Last Updated
November 1, 2018
Sponsor
Flatley Discovery Lab LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03527095
Brief Title
A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
June 21, 2018 (Actual)
Study Completion Date
June 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Flatley Discovery Lab LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regimen A
Arm Type
Experimental
Arm Description
FDL169 200 mg reference tablet
Arm Title
Regimen B
Arm Type
Experimental
Arm Description
FDL169 200 mg testing tablet 1
Arm Title
Regimen C
Arm Type
Experimental
Arm Description
FDL169 200 mg testing tablet 2
Arm Title
Regimen D
Arm Type
Experimental
Arm Description
FDL169 200 mg testing tablet 1 or 2 with high fat diet
Arm Title
Regimen E
Arm Type
Experimental
Arm Description
FDL169 200 mg testing tablet 1 or 2, fasted
Arm Title
Regimen F
Arm Type
Experimental
Arm Description
FDL169 200 mg testing tablet 1 or 2, with standard diet
Intervention Type
Drug
Intervention Name(s)
FDL169
Intervention Description
CFTR corrector
Primary Outcome Measure Information:
Title
Relative bioavailability of FDL169 and its metabolites with different formulations
Description
To determine the relative bioavailability of FDL169 and its metabolites M1 and M3, following different tablet formulations compared to a reference tablet
Time Frame
17 weeks
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
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.
Time Frame
17 weeks
Title
Pharmacokinetic parameters, Cmax
Description
The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3 , maximal plasma concentration (Cmax)
Time Frame
17 weeks
Title
Pharmacokinetic parameters, Tmax
Description
The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; maximal concentration (Tmax)
Time Frame
17 weeks
Title
Pharmacokinetic parameters, AUC
Description
The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; area under the plasma concentration curve (AUC)
Time Frame
17 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Ordonez
Organizational Affiliation
Flatley Discovery Lab
Official's Role
Study Chair
Facility Information:
Facility Name
Quotient Sciences
City
Ruddington
State/Province
Nottingham
ZIP/Postal Code
NG11 6JS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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