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A Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

FDL176 & FDL169 coadministration

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

Exclusion Criteria:

Prior or ongoing medical condition, medical history, physical findings, ECG findings or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the subject or would place the subject at increased risk.
History of long QT syndrome and/or QT corrected according to Fridericia's formula (QTcF) interval (>450 msec) or QTcF >450 msec at Screening or Day -1.
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active.
Use of any prescription drugs within 14 days or 5 half-lives (whichever is longer) before the first dose of IMP, unless in the opinion of the Investigator (or delegate) .
Use of any non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) before the first dose of IMP.
Use of any prescription and non-prescription medications that are strong inhibitors or moderate inducers of cytochrome P450 3A, within 28 days before the first dose of IMP.
Participation in another clinical trial involving receipt of an IMP within the past 90 days.
Prior exposure to FDL169 or FDL176
Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase >1.5 x upper limit of normal (ULN) at screening.
Serum creatinine or total bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%).
Abnormal renal function at screening, defined as estimated glomerular filtration rate <60 mL/min using the Modification of Diet in Renal Disease (MDRD) equation.
History of human immunodeficiency virus (HIV) or positive HIV, hepatitis B or hepatitis C results at screening.
Positive urinary drugs of abuse screen at Screening or Day -1, or positive alcohol breath test at Screening or Day -1. Consumption of alcohol within 24 h prior to admission.

Sites / Locations

Quotient Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part 1:FDL176 & FDL169 coadministration

Part 2:FDL176 & FDL169 coadministration

Arm Description

To receive a single dose of FDL176 on Day 1, followed up FDL169 TID starting Day 8; and another single dose of FDL176 on Day 22.

To receive FDL176 QD starting Day 1, and FDL169 TID starting Day 8

Outcomes

Primary Outcome Measures

Pharmacokinetic parameters, Cmax

The pharmacokinetic parameters of FDL176 when co-administered with FDL169, compared to the pharmacokinetics of FDL176 alone; maximal plasma concentration (Cmax)

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events

Safety and tolerability of FDL176 when co-administered with FDL169, compared to FDL176 alone. as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s.

Full Information

NCT ID

NCT03516331

First Posted

April 24, 2018

Last Updated

November 1, 2018

Sponsor

Flatley Discovery Lab LLC

1. Study Identification

Unique Protocol Identification Number

NCT03516331

Brief Title

A Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects

Official Title

A Phase 1, Open Label, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

March 7, 2018 (Actual)

Primary Completion Date

August 22, 2018 (Actual)

Study Completion Date

August 22, 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

Yes

5. Study Description

Brief Summary

This is an 2-part study. Part 1 will assess the safety, tolerability and pharmacokinetics of single doses of FDL176 with and without co-administration of FDL169. Part 2 will assess the safety, tolerability and pharmacokinetics of repeated doses of FDL176 with and without co-administration of FDL169 .

Detailed Description

This is an open-label, non-randomised, single-sequence 2-part study. Enrolment into Part 2 of the study will begin after Part 1 is complete, and a review of safety and pharmacokinetic data has been completed.Part 1 will assess the safety, tolerability and pharmacokinetics of single doses of FDL176 with and without co-administration of FDL169. Part 2 will assess the safety, tolerability and pharmacokinetics of repeated doses of FDL176 once daily (QD) with and without co-administration of FDL169.

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

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1:FDL176 & FDL169 coadministration

Arm Type

Experimental

Arm Description

To receive a single dose of FDL176 on Day 1, followed up FDL169 TID starting Day 8; and another single dose of FDL176 on Day 22.

Arm Title

Part 2:FDL176 & FDL169 coadministration

Arm Type

Experimental

Arm Description

To receive FDL176 QD starting Day 1, and FDL169 TID starting Day 8

Intervention Type

Drug

Intervention Name(s)

FDL176 & FDL169 coadministration

Intervention Description

CFTR corrector and potentiator

Primary Outcome Measure Information:

Title

Pharmacokinetic parameters, Cmax

Description

The pharmacokinetic parameters of FDL176 when co-administered with FDL169, compared to the pharmacokinetics of FDL176 alone; maximal plasma concentration (Cmax)

Time Frame

72 days

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events

Description

Safety and tolerability of FDL176 when co-administered with FDL169, compared to FDL176 alone. as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s.

Time Frame

72 days

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 Exclusion Criteria: Prior or ongoing medical condition, medical history, physical findings, ECG findings or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the subject or would place the subject at increased risk. History of long QT syndrome and/or QT corrected according to Fridericia's formula (QTcF) interval (>450 msec) or QTcF >450 msec at Screening or Day -1. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active. Use of any prescription drugs within 14 days or 5 half-lives (whichever is longer) before the first dose of IMP, unless in the opinion of the Investigator (or delegate) . Use of any non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) before the first dose of IMP. Use of any prescription and non-prescription medications that are strong inhibitors or moderate inducers of cytochrome P450 3A, within 28 days before the first dose of IMP. Participation in another clinical trial involving receipt of an IMP within the past 90 days. Prior exposure to FDL169 or FDL176 Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase >1.5 x upper limit of normal (ULN) at screening. Serum creatinine or total bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%). Abnormal renal function at screening, defined as estimated glomerular filtration rate <60 mL/min using the Modification of Diet in Renal Disease (MDRD) equation. History of human immunodeficiency virus (HIV) or positive HIV, hepatitis B or hepatitis C results at screening. Positive urinary drugs of abuse screen at Screening or Day -1, or positive alcohol breath test at Screening or Day -1. Consumption of alcohol within 24 h prior to admission.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claudia Ordonez, MD

Organizational Affiliation

Flatley Discovery Lab

Official's Role

Study Chair

Facility Information:

Facility Name

Quotient Sciences

City

Nottingham

State/Province

Ruddington

ZIP/Postal Code

NG11 6JS

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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A Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects

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