Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy Subjects

A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects

This is a single-center, randomized, double-blind, placebo-controlled, ascending single-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating doses of VIA-3196 or matching placebo.

Study Overview

• Status: Completed
• Conditions: Drug Safety
• Intervention / Treatment: Drug: Placebo; Drug: VIA-3196

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Cetero Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The subject must be willing and able to provide written informed consent.
• Healthy, non-smoking, males and females between the ages of 18 and 55 years of age (inclusive).
• If female, the subject is of non-child bearing potential (i.e., surgically [bilateral oophorectomy, hysterectomy, or tubal ligation] or naturally sterile [>12 consecutive months without menses]). Verify by FSH at screening as appropriate.
• Body weight > 50 kg and BMI between 18 and 30 kg/m2 (inclusive).
• LDL cholesterol > 85 mg/dL.
• No clinically significant abnormal findings on blood pressure, heart rate, physical examination, clinical laboratory tests or 12-lead ECG.

Key Exclusion Criteria:

• History of thyroid disorder or abnormal thyroid function tests at screening. Repeat testing is allowed at the discretion of the Investigator.
• History of unexplained syncope.
• History of hepatobiliary disease; or AST, ALT or direct bilirubin greater than the upper limit of reference range at screening.
• Positive screening test for HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody.
• Abnormal screening ECG: including machine-read QTc >450 msec, QRS >110 msec, intermittent bundle branch block, frequent premature atrial or premature ventricular contractions, or any rhythm other than normal sinus rhythm which is interpreted by the Investigator to be clinically significant.
• History of sensitivity to a similar study drug (e.g., Karo Bio KB2115 or Metabasis MB7811), or a history of important drug or other allergy (except for untreated, asymptomatic seasonal allergies at time of dosing).
• Sensitivity to thyroid medication.
• History of asthma, or intolerance to beta-blockers.
• Use of acetaminophen within 7 days before dosing and throughout the study.
• History of regular use of tobacco or nicotine containing products within the past 6 months.
• Positive urine drug screen or alcohol test at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Multiple, single-dose, ascending dosing groups (cohorts) will be evaluated.	Drug: Placebo; Oral, matching number of placebo capsule(s) with active arm
Experimental: VIA-3196; Multiple, single-dose, ascending dosing groups (cohorts) will be evaluated.	Drug: VIA-3196; Oral, capsule(s); Other Names: VIA-3196, Resmetirom

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events as a measure of safety and tolerability of VIA-3196	Evaluation will start from predose (Day -1) until the follow-up visit (Day 7 to 11)	up to 12 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of VIA-3196	Assessed with and without food	0 to 72 hours

Collaborators and Investigators

• Sponsor: Madrigal Pharmaceuticals, Inc.
• Investigators: Study Chair: Rebecca Taub, MD, Madrigal Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 2, 2011
• First Submitted That Met QC Criteria: June 3, 2011
• First Posted (Estimated): June 7, 2011

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: VIA-3196-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No