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

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ClinicalTrials.gov Identifier: NCT03527095
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Flatley Discovery Lab LLC

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: FDL169 Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 5, 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Regimen A
FDL169 200 mg reference tablet
Drug: FDL169
CFTR corrector

Experimental: Regimen B
FDL169 200 mg testing tablet 1
Drug: FDL169
CFTR corrector

Experimental: Regimen C
FDL169 200 mg testing tablet 2
Drug: FDL169
CFTR corrector

Experimental: Regimen D
FDL169 200 mg testing tablet 1 or 2 with high fat diet
Drug: FDL169
CFTR corrector

Experimental: Regimen E
FDL169 200 mg testing tablet 1 or 2, fasted
Drug: FDL169
CFTR corrector

Experimental: Regimen F
FDL169 200 mg testing tablet 1 or 2, with standard diet
Drug: FDL169
CFTR corrector




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Pharmacokinetic parameters, Cmax [ Time Frame: 17 weeks ]
    The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3 , maximal plasma concentration (Cmax)

  3. Pharmacokinetic parameters, Tmax [ Time Frame: 17 weeks ]
    The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; maximal concentration (Tmax)

  4. 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)



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527095


Contacts
Contact: Timothy O'Toole +1 6179043708 timothyotoole@flatleydiscoverylab.com

Locations
United Kingdom
Quotient Sciences Recruiting
Ruddington, Nottingham, United Kingdom, NG11 6JS
Contact: Anna Robinson    +44 (0)115 931 5515    Anna.Robinson@quotientsciences.com   
Sponsors and Collaborators
Flatley Discovery Lab LLC
Investigators
Study Chair: Claudia Ordonez Flatley Discovery Lab

Responsible Party: Flatley Discovery Lab LLC
ClinicalTrials.gov Identifier: NCT03527095     History of Changes
Other Study ID Numbers: FDL169-2017-06
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Flatley Discovery Lab LLC:
Cystic Fibrosis

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases