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An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

FDL169

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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 Criteria:

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)

Sites / Locations

Quotient Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

FDL169 Dose Level 1,sublingual to oral

FDL169 Dose Level 1 dosing,oral to sublingual

FDL169 Dose Level 2 sublingual to oral,Optional

FDL169 Dose Level 2 oral to sublingual,Optional

Arm Description

Dose level 1 sublingual first and oral second.

Dose level 1 oral first and sublingual second.

Dose level 2 sublingual first and oral second.

Dose level 2 oral first and sublingual second.

Outcomes

Primary Outcome Measures

Pharmacokinetic parameters, Cmax

The pharmacokinetic parameters of FDL169; maximal plasma concentration (Cmax)

Pharmacokinetic parameters, Tmax

The pharmacokinetic parameters of FDL169; maximal concentration (Tmax)

Pharmacokinetic parameters, AUC

The pharmacokinetic parameters of FDL169; area under the plasma concentration curve (AUC)

Pharmacokinetic parameters, CL/F

The pharmacokinetic parameters of FDL169; clearance (CL/F)

Pharmacokinetic parameters, V/F

The pharmacokinetic parameters of FDL169; apparent volume of distribution (V/F)

Ratio of pharmacokinetic parameters, AUC, between sublingual and oral formulation

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

Incidence of Treatment-Emergent Adverse Events

Safety and tolerability of FDL169 as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s.

Full Information

NCT ID

NCT03424252

First Posted

January 31, 2018

Last Updated

November 1, 2018

Sponsor

Flatley Discovery Lab LLC

1. Study Identification

Unique Protocol Identification Number

NCT03424252

Brief Title

An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

December 18, 2017 (Actual)

Primary Completion Date

January 15, 2018 (Actual)

Study Completion Date

January 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Flatley Discovery Lab LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

Cystic Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FDL169 Dose Level 1,sublingual to oral

Arm Type

Experimental

Arm Description

Dose level 1 sublingual first and oral second.

Arm Title

FDL169 Dose Level 1 dosing,oral to sublingual

Arm Type

Experimental

Arm Description

Dose level 1 oral first and sublingual second.

Arm Title

FDL169 Dose Level 2 sublingual to oral,Optional

Arm Type

Experimental

Arm Description

Dose level 2 sublingual first and oral second.

Arm Title

FDL169 Dose Level 2 oral to sublingual,Optional

Arm Type

Experimental

Arm Description

Dose level 2 oral first and sublingual second.

Intervention Type

Drug

Intervention Name(s)

FDL169

Intervention Description

Cystic Fibrosis Transmembrane Regulator (CFTR) corrector

Primary Outcome Measure Information:

Title

Pharmacokinetic parameters, Cmax

Description

The pharmacokinetic parameters of FDL169; maximal plasma concentration (Cmax)

Time Frame

7 weeks

Title

Pharmacokinetic parameters, Tmax

Description

The pharmacokinetic parameters of FDL169; maximal concentration (Tmax)

Time Frame

7 weeks

Title

Pharmacokinetic parameters, AUC

Description

The pharmacokinetic parameters of FDL169; area under the plasma concentration curve (AUC)

Time Frame

7 weeks

Title

Pharmacokinetic parameters, CL/F

Description

The pharmacokinetic parameters of FDL169; clearance (CL/F)

Time Frame

7 weeks

Title

Pharmacokinetic parameters, V/F

Description

The pharmacokinetic parameters of FDL169; apparent volume of distribution (V/F)

Time Frame

7 weeks

Title

Ratio of pharmacokinetic parameters, AUC, between sublingual and oral formulation

Description

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

Time Frame

7 weeks

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events

Description

Safety and tolerability of FDL169 as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s.

Time Frame

7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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)

Facility Information:

Facility Name

Quotient Sciences

City

Nottingham

ZIP/Postal Code

NG116JS

Country

United Kingdom

12. IPD Sharing Statement

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An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects

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