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Trial record 6 of 8 for:    FDL169 | Cystic Fibrosis

An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations 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: NCT03424252
Recruitment Status : Completed
First Posted : February 6, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Flatley Discovery Lab LLC

Tracking Information
First Submitted Date  ICMJE January 31, 2018
First Posted Date  ICMJE February 6, 2018
Last Update Posted Date November 2, 2018
Actual Study Start Date  ICMJE December 18, 2017
Actual Primary Completion Date January 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
  • Pharmacokinetic parameters, Cmax [ Time Frame: 7 weeks ]
    The pharmacokinetic parameters of FDL169; maximal plasma concentration (Cmax)
  • Pharmacokinetic parameters, Tmax [ Time Frame: 7 weeks ]
    The pharmacokinetic parameters of FDL169; maximal concentration (Tmax)
  • Pharmacokinetic parameters, AUC [ Time Frame: 7 weeks ]
    The pharmacokinetic parameters of FDL169; area under the plasma concentration curve (AUC)
  • Pharmacokinetic parameters, CL/F [ Time Frame: 7 weeks ]
    The pharmacokinetic parameters of FDL169; clearance (CL/F)
  • Pharmacokinetic parameters, V/F [ Time Frame: 7 weeks ]
    The pharmacokinetic parameters of FDL169; apparent volume of distribution (V/F)
  • Ratio of pharmacokinetic parameters, AUC, between sublingual and oral formulation [ Time Frame: 7 weeks ]
    The pharmacokinetic parameters of FDL169; area under the plasma concentration curve (AUC) of FDL169 and its M1 metabolite following sublingual dosing compared to oral dosing
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
Incidence of Treatment-Emergent Adverse Events [ Time Frame: 7 weeks ]
Safety and tolerability of FDL169 as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s.
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 An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects
Official Title  ICMJE A Phase 1, Open-label, Crossover, Randomised Study to Evaluate the Pharmacokinetic Profile of FDL169 Sublingual Formulations in the Fed State in Healthy Subjects
Brief Summary Two parts, two periods, crossover study with part 2 is optional. In both parts, subjects will be randomized to sequentially receive both sublingual and oral formulations of FDL169.
Detailed Description This is a single center, open label study on healthy volunteers. The study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of Part 1 data. Part 1 and optional Part 2 have randomized, 2 period crossover designs. Subjects will randomized to 1 of 2 treatment sequences in order to receive 2 single doses of FDL169 on separate occasions, one as a sublingual administration and one as an oral administration. There will be a minimum washout period of 10 days between FDL169 administrations. The duration of each part is approximately 7 weeks from screening to follow up.
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
Cystic Fibrosis Transmembrane Regulator (CFTR) corrector
Study Arms  ICMJE
  • Experimental: FDL169 Dose Level 1,sublingual to oral
    Dose level 1 sublingual first and oral second.
    Intervention: Drug: FDL169
  • Experimental: FDL169 Dose Level 1 dosing,oral to sublingual
    Dose level 1 oral first and sublingual second.
    Intervention: Drug: FDL169
  • Experimental: FDL169 Dose Level 2 sublingual to oral,Optional
    Dose level 2 sublingual first and oral second.
    Intervention: Drug: FDL169
  • Experimental: FDL169 Dose Level 2 oral to sublingual,Optional
    Dose level 2 oral first and sublingual second.
    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: January 31, 2018)
24
Actual Study Completion Date  ICMJE January 15, 2018
Actual Primary Completion Date January 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy males or non-pregnant, non-lactating healthy females
  2. Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
  3. Must agree to follow the study's contraception requirement Subject has normal healthy oral mucosa with no clinically significant findings

Exclusion Criteria:

  1. Subjects who have received any IMP in a clinical research study within the previous 3 months
  2. Subjects who have previously received FDL169
  3. History of any drug or alcohol abuse in the past 2 years
  4. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
  5. Current smokers and those who have smoked within the last 12 months
  6. Females of childbearing potential who are pregnant or lactating (all female subjects must have a negative urine pregnancy test at screening and each admission). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone [FSH] concentration >40 mIU/mL)
  7. Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase level >1.5 x upper limit of normal at screening
  8. Abnormal renal function at screening, defined as estimated glomerular filtration rate <60 mL/min using the Modification of Diet in Renal Disease (MDRD) equation
  9. Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in)
  10. Positive drugs of abuse test result
  11. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
  12. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
  13. Subjects with a history of abdominal surgery eg cholecystectomy (appendectomy is allowed unless procedure was within 12 months)
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 NCT03424252
Other Study ID Numbers  ICMJE FDL169-2017-05
Has Data Monitoring Committee No
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 Not Provided
Responsible Party Flatley Discovery Lab LLC
Study Sponsor  ICMJE Flatley Discovery Lab LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Flatley Discovery Lab LLC
Verification Date February 2018

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