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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01367873
Other study ID # VIA-3196-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 2011
Est. completion date October 2011

Study information

Verified date August 2023
Source Madrigal Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Oral, matching number of placebo capsule(s) with active arm
VIA-3196
Oral, capsule(s)

Locations

Country Name City State
United States Cetero Research Fargo North Dakota

Sponsors (1)

Lead Sponsor Collaborator
Madrigal Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Plasma concentration of VIA-3196 Assessed with and without food 0 to 72 hours
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