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

A Randomized, Double-blind, Placebo-Controlled, Ascending Multiple-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 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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • PRACS Institute (formerly Cetero Research)

Participation Criteria

Eligibility Criteria

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

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 ≥ 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.

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
Experimental: VIA-3196	Drug: VIA-3196; Oral, daily dosing for 14 days
Placebo Comparator: Placebo; Multiple, ascending dosing groups (cohorts) will be evaluated.	Drug: Placebo; Oral, daily-dosing for 14 days; matching number of placebo capsule(s) with active arm

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 21)	up to 22 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of VIA-3196	Assessed without food	0 to 24 hours on Day 1 and Day 14
Lipid level changes following administration of VIA-3196		Day 1 to 14

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 24, 2012
• First Submitted That Met QC Criteria: January 24, 2012
• First Posted (Estimate): January 27, 2012

Study Record Updates

• Last Update Posted (Estimate): December 6, 2012
• Last Update Submitted That Met QC Criteria: December 4, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: VIA-3196-02