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

Phase 1

Completed

• Conditions: Idiopathic pulmonary fibrosis; Primary Sclerosing Cholangitis; Respiratory - Other respiratory disorders / diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12620000573954
• Lead Sponsor: Pliant Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-04-20
• Study Start: 2020-05-15
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. 18 to 55 years
2. 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.
3. Body weight greater than or equal to 50 kg at the Screening Visit.
4. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
5. Participants must use adequate contraception for male and female participants of childbearing potential.
6. Understand the study procedures and agrees to participate in the study by giving written informed consent.

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the relative oral bioavailability of a tablet vs. a solution of PLN-74809 in healthy participants.<br><br>Single -dose pharmacokinetics (PK) of PLN-74809 will be assessed using plasma blood samples. <br><br>Parameters to be examined include: AUC, Cmax, tmax, t 1/2, CL/F, VzF, R cmax, R auc.[Blood samples for the assay of PLN-74809 will be collected at up to 19 pre-determined timepoints over the 8 day confinement periods of treatment period 1 and treatment period 2.<br><br>]

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of a single dose of PLN-74809 in healthy<br>participants.[Safety and tolerability of PLN-74809 assessments will be collected for 28 days (+/-3 days) following the first dose of PLN-74809. <br><br>Safety and tolerability will be assessed by physical exam, vital signs, ECG and laboratory testing. <br><br>Monitoring for adverse events and concomitant medications will be conducted at frequent intervals when housed in the clinic from the time of the signed consent to the End of Study visit.]