Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03527095
Recruitment Status : Completed
First Posted : May 16, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Flatley Discovery Lab LLC

Tracking Information
First Submitted Date  ICMJE May 4, 2018
First Posted Date  ICMJE May 16, 2018
Last Update Posted Date November 2, 2018
Actual Study Start Date  ICMJE April 5, 2018
Actual Primary Completion Date June 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
Relative bioavailability of FDL169 and its metabolites with different formulations [ Time Frame: 17 weeks ]
To determine the relative bioavailability of FDL169 and its metabolites M1 and M3, following different tablet formulations compared to a reference tablet
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 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 [ Time Frame: 17 weeks ]
    The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3 , maximal plasma concentration (Cmax)
  • Pharmacokinetic parameters, Tmax [ Time Frame: 17 weeks ]
    The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; maximal concentration (Tmax)
  • Pharmacokinetic parameters, AUC [ Time Frame: 17 weeks ]
    The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; area under the plasma concentration curve (AUC)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE Drug: FDL169
CFTR corrector
Study Arms  ICMJE
  • Experimental: Regimen A
    FDL169 200 mg reference tablet
    Intervention: Drug: FDL169
  • Experimental: Regimen B
    FDL169 200 mg testing tablet 1
    Intervention: Drug: FDL169
  • Experimental: Regimen C
    FDL169 200 mg testing tablet 2
    Intervention: Drug: FDL169
  • Experimental: Regimen D
    FDL169 200 mg testing tablet 1 or 2 with high fat diet
    Intervention: Drug: FDL169
  • Experimental: Regimen E
    FDL169 200 mg testing tablet 1 or 2, fasted
    Intervention: Drug: FDL169
  • Experimental: Regimen F
    FDL169 200 mg testing tablet 1 or 2, with standard diet
    Intervention: Drug: FDL169
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2018)
11
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2018)
12
Actual Study Completion Date  ICMJE June 21, 2018
Actual Primary Completion Date June 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03527095
Other Study ID Numbers  ICMJE FDL169-2017-06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Flatley Discovery Lab LLC
Study Sponsor  ICMJE Flatley Discovery Lab LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Claudia Ordonez Flatley Discovery Lab
PRS Account Flatley Discovery Lab LLC
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP