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

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



Sponsors


Source

Flatley Discovery Lab LLC

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

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.

Overall Status

Recruiting

Start Date

2018-04-05

Completion Date

2018-07-01

Primary Completion Date

2018-07-01

Phase

Phase 1

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Relative bioavailability of FDL169 and its metabolites with different formulations
17 weeks

Secondary Outcome

Measure

Time Frame

Incidence of Treatment-Emergent Adverse Events
17 weeks
Pharmacokinetic parameters, Cmax
17 weeks
Pharmacokinetic parameters, Tmax
17 weeks
Pharmacokinetic parameters, AUC
17 weeks

Enrollment

12

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

CFTR corrector

Arm Group Label

Regimen A

Regimen B

Regimen C

Regimen D

Regimen E

Regimen F



Eligibility

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

Gender

All

Minimum Age

18 Years

Maximum Age

55 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

Claudia Ordonez
Study Chair
Flatley Discovery Lab

Overall Contact

Last Name

Timothy O'Toole

Phone

+1 6179043708

Email



Location

Facility

Status

Contact

Quotient Sciences
Ruddington Nottingham NG11 6JS United Kingdom
Recruiting
Last Name: Anna Robinson
Phone: +44 (0)115 931 5515
Email: [email protected]

Location Countries

Country

United Kingdom


Verification Date

2018-05-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Keyword


Has Expanded Access

No

Condition Browse


Number Of Arms

6

Arm Group

Arm Group Label

Regimen A

Arm Group Type

Experimental

Description

FDL169 200 mg reference tablet


Arm Group Label

Regimen B

Arm Group Type

Experimental

Description

FDL169 200 mg testing tablet 1


Arm Group Label

Regimen C

Arm Group Type

Experimental

Description

FDL169 200 mg testing tablet 2


Arm Group Label

Regimen D

Arm Group Type

Experimental

Description

FDL169 200 mg testing tablet 1 or 2 with high fat diet


Arm Group Label

Regimen E

Arm Group Type

Experimental

Description

FDL169 200 mg testing tablet 1 or 2, fasted


Arm Group Label

Regimen F

Arm Group Type

Experimental

Description

FDL169 200 mg testing tablet 1 or 2, with standard diet



Firstreceived Results Date

N/A

Patient Data

Sharing Ipd

Undecided


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Crossover Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

May 4, 2018

Study First Submitted Qc

May 15, 2018

Study First Posted

May 16, 2018

Last Update Submitted

May 15, 2018

Last Update Submitted Qc

May 15, 2018

Last Update Posted

May 16, 2018


ClinicalTrials.gov processed this data on August 24, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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