Status:
COMPLETED
An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects
Lead Sponsor:
Flatley Discovery Lab LLC
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 da...
Eligibility Criteria
Inclusion
- Healthy males or non-pregnant, non-lactating healthy females
- Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Must agree to follow the study's contraception requirement Subject has normal healthy oral mucosa with no clinically significant findings
Exclusion
- Subjects who have received any IMP in a clinical research study within the previous 3 months
- Subjects who have previously received FDL169
- History of any drug or alcohol abuse in the past 2 years
- 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)
- Current smokers and those who have smoked within the last 12 months
- 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)
- Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase level \>1.5 x upper limit of normal at screening
- Abnormal renal function at screening, defined as estimated glomerular filtration rate \<60 mL/min using the Modification of Diet in Renal Disease (MDRD) equation
- Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in)
- Positive drugs of abuse test result
- 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 gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Subjects with a history of abdominal surgery eg cholecystectomy (appendectomy is allowed unless procedure was within 12 months)
Key Trial Info
Start Date :
December 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2018
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03424252
Start Date
December 18 2017
End Date
January 15 2018
Last Update
November 2 2018
Active Locations (1)
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1
Quotient Sciences
Nottingham, United Kingdom, NG116JS