A study to evaluate the safety, tolerability, processing by the body, and response of the body to the drug VK2735 in healthy adults

Phase 1

Completed

• Conditions: on-alcoholic steatohepatitis (NASH); Digestive System; Other specified inflammatory liver diseases

• Registration Number: ISRCTN47896018
• Lead Sponsor: Viking Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-10
• Study Completion: 2022-12-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. Participants must be capable of giving signed informed consent
2. Participants must be medically healthy, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of IP in the opinion of the Investigator
3. Participant body weight must have been stable (no change greater than 5%) for a minimum 8 weeks prior to Screening
4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures
5. Willing to comply with contraception requirements

Exclusion Criteria

1. Participants with any level of disease or organ system dysfunction as identified during physical examination, medical history or laboratory testing, as assessed by the PI
2. Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption
3. Participants may be excluded from the study if they have conditions that might compromise safety or other endpoints in the study as judged by the Sponsor (or designee) or Investigator
4. History or presence of clinically significant acute or unstable cerebrovascular (stroke), hepatic, renal, gastrointestinal, pulmonary, immunological, endocrine, diabetes, hematological, oncological, or central nervous disorder that in the opinion of the Investigator would pose a significant risk for the participant
5. Use of any investigational drug or product, or participation in an investigational drug study within 30 days prior to dosing or 5 half-lives of the drug (whichever is longest)
6. Active smoker and/or user of nicotine-containing products unless the participant agrees to discontinue smoking/use of nicotine-containing products from 2 weeks before first IP dose administration through to study completion, including the follow-up period
7. Have serum triglycerides >5.65 mmol/l (500 mg/dl) at Screening
8. Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety measured as the incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious AEs (TESAEs) measured between baseline and 16 days for part A of the study, and between baseline and 43 days for part B of the study

Secondary Outcome Measures

Name	Time	Method
Plasma pharmacokinetic analysis of VK2735 measured using Cmax, Tmax, AUC, and other plasma PK analysis of VK2735 from blood samples taken between 30 min pre-dose and 168 h post-dose for part A and part B of the study