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

NCT ID: NCT01519531

Last Updated: 2012-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-11-30

Brief Summary

This is a single-center, randomized, double-blind, placebo-controlled, ascending multiple-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. Subjects will be dosed daily for 14 days.

Conditions

Drug Safety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

VIA-3196

Group Type: EXPERIMENTAL

VIA-3196

Intervention Type: DRUG

Oral, daily dosing for 14 days

Placebo

Multiple, ascending dosing groups (cohorts) will be evaluated.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral, daily-dosing for 14 days; matching number of placebo capsule(s) with active arm

Interventions

Placebo

Oral, daily-dosing for 14 days; matching number of placebo capsule(s) with active arm

Intervention Type: DRUG

VIA-3196

Oral, daily dosing for 14 days

Intervention Type: DRUG

Eligibility Criteria

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 ≥ 110mg/dL.

Exclusion Criteria

• History of thyroid disorder or abnormal thyroid function tests at screening. Repeat testing is allowed once 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 (confirmed by manual over read), 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) unless deemed not clinically significant by the Investigator.
• History of 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 or Day -1.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Madrigal Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Taub, MD

Role: STUDY_DIRECTOR

Madrigal Pharmaceuticals

Locations

PRACS Institute (formerly Cetero Research)

Fargo, North Dakota, United States

Countries

United States

Other Identifiers

VIA-3196-02

Identifier Type: -

Identifier Source: org_study_id