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

Drug Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519531
• Other study ID #: VIA-3196-02
• Status: Completed
• Phase: Phase 1
• First received: January 24, 2012
• Last updated: December 4, 2012
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Madrigal Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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 = 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Safety

Intervention

Drug:
• Placebo
Oral, daily-dosing for 14 days; matching number of placebo capsule(s) with active arm
• VIA-3196
Oral, daily dosing for 14 days

Locations

Country	Name	City	State
United States	PRACS Institute (formerly 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 21)	up to 22 days	Yes
Secondary	Plasma concentration of VIA-3196	Assessed without food	0 to 24 hours on Day 1 and Day 14	No
Secondary	Lipid level changes following administration of VIA-3196		Day 1 to 14	No