Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
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

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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Crossover, Randomised Study to Evaluate the Pharmacokinetic Profile of FDL169 Sublingual Formulations in the Fed State in Healthy Subjects
Actual Study Start Date : December 18, 2017
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : January 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: FDL169 Dose Level 1,sublingual to oral
Dose level 1 sublingual first and oral second.
Drug: FDL169
Cystic Fibrosis Transmembrane Regulator (CFTR) corrector

Experimental: FDL169 Dose Level 1 dosing,oral to sublingual
Dose level 1 oral first and sublingual second.
Drug: FDL169
Cystic Fibrosis Transmembrane Regulator (CFTR) corrector

Experimental: FDL169 Dose Level 2 sublingual to oral,Optional
Dose level 2 sublingual first and oral second.
Drug: FDL169
Cystic Fibrosis Transmembrane Regulator (CFTR) corrector

Experimental: FDL169 Dose Level 2 oral to sublingual,Optional
Dose level 2 oral first and sublingual second.
Drug: FDL169
Cystic Fibrosis Transmembrane Regulator (CFTR) corrector




Primary Outcome Measures :
  1. Pharmacokinetic parameters, Cmax [ Time Frame: 7 weeks ]
    The pharmacokinetic parameters of FDL169; maximal plasma concentration (Cmax)

  2. Pharmacokinetic parameters, Tmax [ Time Frame: 7 weeks ]
    The pharmacokinetic parameters of FDL169; maximal concentration (Tmax)

  3. Pharmacokinetic parameters, AUC [ Time Frame: 7 weeks ]
    The pharmacokinetic parameters of FDL169; area under the plasma concentration curve (AUC)

  4. Pharmacokinetic parameters, CL/F [ Time Frame: 7 weeks ]
    The pharmacokinetic parameters of FDL169; clearance (CL/F)

  5. Pharmacokinetic parameters, V/F [ Time Frame: 7 weeks ]
    The pharmacokinetic parameters of FDL169; apparent volume of distribution (V/F)

  6. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT03424252


Locations
Layout table for location information
United Kingdom
Quotient Sciences
Nottingham, United Kingdom, NG116JS
Sponsors and Collaborators
Flatley Discovery Lab LLC
Layout table for additonal information
Responsible Party: Flatley Discovery Lab LLC
ClinicalTrials.gov Identifier: NCT03424252    
Other Study ID Numbers: FDL169-2017-05
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: February 2018

Layout table for additional information
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:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases