CompletedPhase 1ACTRN12620000573954

The Relative Oral Bioavailability of a Tablet Formulation vs a Solution of PLN-74809 in Healthy Participants

Sponsor

Pliant Therapeutics, Inc.

Enrollment

24 participants

Start Date

Jan 24, 2020

Study Type

Interventional

Conditions

Primary Sclerosing Cholangitis

Summary

Pliant Inc. is developing PLN-74809-000 (hereafter referred to as PLN-74809) for the treatment of idiopathic pulmonary fibrosis (IPF) and for the treatment of primary sclerosing cholangitis (PSC). PLN-74809 is expected to exert anti-fibrotic effects through mechanisms that are different from those of current standards of care for the treatment of IPF. IPF remains a clear area of unmet medical need, warranting the development of novel therapies aimed at providing a clinically meaningful improvement for the IPF population. An oral solution of PLN-74809, which has been used in the clinical studies conducted thus far, is to be replaced by a newly developed tablet formulation. Accordingly, the current study is designed to determine the relative bioavailability of the tablet vs the solution as a reference in healthy participants.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria7

18 to 55 years
Good general health, with no significant medical history and no clinically significant
abnormalities at screening and/or before administration of the initial dose of study drug.
Body weight greater than or equal to 50 kg at the Screening Visit.
Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
Participants must use adequate contraception for male and female participants of childbearing potential.
Understand the study procedures and agrees to participate in the study by giving written informed consent.

Exclusion Criteria10

History of clinically significant abnormalities or diseases.
Pregnant or lactating females.
Positive test for hepatitis C antibody (HCVAb), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
Positive toxicology screening panel
History of substance abuse or dependency or history of recreational drug use.
Alcohol consumption greater than 14 drinks per week for males (7 for females).
Smokers or ‘vapers’ (cigarette or other modalities).
Unable to refrain from or anticipates the use of any medications, including prescription and non-prescription drugs and herbal supplements.
Unlikely to comply with the study protocol or, in the opinion of the Investigator, would not be a suitable candidate for participation in the study.
Have participated in any other investigational drug trial within 30 days or 5 half-lives (whichever is longer) of dosing in the present study.

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Interventions

This will be a single center, 2-period, sequence-randomized, crossover, single-dose, open-label study in 24 healthy participants. Participants will receive a single dose of PLN 74809 on 2 occasions

This will be a single center, 2-period, sequence-randomized, crossover, single-dose, open-label study in 24 healthy participants. Participants will receive a single dose of PLN 74809 on 2 occasions in randomized sequence, as an 40-mg oral solution and as a 40-mg tablet. The 2 administrations will be separated by a washout period of approximately 2 weeks. Intervention is administered directly by staff at a Phase 1 unit. Laboratory test will also be monitored to assess adherence.