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

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ClinicalTrials.gov Identifier: NCT03516331
Recruitment Status : Completed
First Posted : May 4, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Flatley Discovery Lab LLC

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 .

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects
Actual Study Start Date : March 7, 2018
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1:FDL176 & FDL169 coadministration
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.
Drug: FDL176 & FDL169 coadministration
CFTR corrector and potentiator

Experimental: Part 2:FDL176 & FDL169 coadministration
To receive FDL176 QD starting Day 1, and FDL169 TID starting Day 8
Drug: FDL176 & FDL169 coadministration
CFTR corrector and potentiator




Primary Outcome Measures :
  1. Pharmacokinetic parameters, Cmax [ Time Frame: 72 days ]
    The pharmacokinetic parameters of FDL176 when co-administered with FDL169, compared to the pharmacokinetics of FDL176 alone; maximal plasma concentration (Cmax)


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 72 days ]
    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.



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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, 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.

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): NCT03516331


Locations
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United Kingdom
Quotient Sciences
Nottingham, Ruddington, United Kingdom, NG11 6JS
Sponsors and Collaborators
Flatley Discovery Lab LLC
Investigators
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Study Chair: Claudia Ordonez, MD Flatley Discovery Lab

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Responsible Party: Flatley Discovery Lab LLC
ClinicalTrials.gov Identifier: NCT03516331     History of Changes
Other Study ID Numbers: FDL169-2017-07
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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