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

Arm | Intervention/treatment |
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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.
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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
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Drug: FDL176 & FDL169 coadministration
CFTR corrector and potentiator |
- 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)
- 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 |
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.

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
United Kingdom | |
Quotient Sciences | |
Nottingham, Ruddington, United Kingdom, NG11 6JS |
Study Chair: | Claudia Ordonez, MD | Flatley Discovery Lab |
Responsible Party: | Flatley Discovery Lab LLC |
ClinicalTrials.gov Identifier: | NCT03516331 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cystic Fibrosis |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |