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A DDI Study of FDL169 and FDL176 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03756922
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Flatley Discovery Lab LLC

Brief Summary:
A DDI study to assess the safety, tolerability and pharmacokinetics of both; doses of FDL176 with and without co-administration of FDL169 and doses of FDL169 with and without co-administration of FDL176.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: FDL169 Drug: FDL176 Phase 1 Phase 2

Detailed Description:
This is an open-label, non-randomised study. Enrolment will be in two parallel and independent parts. 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 FDL169 with and without co-administration of FDL176.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Parallel for Part 1 and Part 2; Sequential for Part 3 and Part 4
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Parts 1, 2, and 3 are Open Label, while Part 4 is randomized and blinded
Primary Purpose: Treatment
Official Title: A Phase 1/2, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects and in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR Mutation
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Part 1
To receive a single dose of FDL176 on Day 1, followed by FDL169 TID for 28 days starting on Day 29; and another single dose of FDL176 on Day 42.
Drug: FDL169
CFTR corrector

Drug: FDL176
CFTR potentiator

Experimental: Part 2
To receive FDL169 TID for 3 days from Day 1, followed by FDL176 QD for 19 days starting on Day 8; and FDL169 TID for 3 days from Day 24.
Drug: FDL169
CFTR corrector

Drug: FDL176
CFTR potentiator

Experimental: Part 3
FDL169 and FDL176 for 28 days and 4 weeks of follow-up
Drug: FDL169
CFTR corrector

Drug: FDL176
CFTR potentiator

Experimental: Part 4
FDL169 and FDL176 for 28 days and 4 weeks of follow-up
Drug: FDL169
CFTR corrector

Drug: FDL176
CFTR potentiator




Primary Outcome Measures :
  1. Pharmacokinetic parameters, Cmax [ Time Frame: Part 1: 14 weeks; Part 2: 12 weeks; Part 3: 12weeks; Part 4: 12 weeks ]
    Part 1: the pharmacokinetic parameters of FDL176 when co-administered with FDL169, compared to the pharmacokinetics of FDL176 alone. Part 2: the pharmacokinetics of FDL169 when co-administered with FDL176, compared to the pharmacokinetics of FDL169 alone. Part 3: PK when co-administered. Part 4: Safety and tolerability with multiple dose co-administration in CF subjects


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Part 1: 14 weeks; Part 2: 12 weeks; Part 3: 12weeks; Part 4: 12 weeks ]
    Safety and tolerability when FDL176 and FDL169 are co-administrated,compared to FDL176 alone, and FDL169 alone, as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s. Part 4: Combination PK and CF transmembrane conductance regulator activity in CF subjects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  • 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 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 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.
  • Consumption of any food or drink containing grapefruit, or Seville oranges (including marmalade and fruit juices) for 14 days before the first dose of IMP.
  • Consumptions or foods containing poppy seeds or involvement in strenuous exercise for 3 days before admission.
  • Known hypersensitivity to any component of the formulation of FDL169 or FDL176.
  • Pregnant or nursing females.
  • History of regular alcohol consumption within 6 months of the study
  • Current smoking or use of tobacco products or substitutes.
  • Poor peripheral venous access.
  • Donation of ≥470 mL blood or loss of blood during surgery or due to trauma within 3 months prior to Day 1.
  • Plasma donation within 7 days prior to Day 1.
  • Failure to satisfy the Investigator of their fitness to participate for any other reason.
  • Site staff, Sponsor staff or first degree family members of site or Sponsor.

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): NCT03756922


Contacts
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Contact: Jingwen Chai +1 6179043705 jingwenchai@flatleydiscoverylab.com
Contact: Timothy O'Toole +1 617 904 3708 timothyotoole@flatleydiscoverylab.com

Locations
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United Kingdom
Celerion GB Ltd Recruiting
Belfast, United Kingdom, BT9 6AD
Contact: Fiona McNeilly         
Sponsors and Collaborators
Flatley Discovery Lab LLC

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Responsible Party: Flatley Discovery Lab LLC
ClinicalTrials.gov Identifier: NCT03756922     History of Changes
Other Study ID Numbers: FDL169-2018-10
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: November 2018

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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:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases