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

NCT01519531 | Completed Phase 1

• 1 other identifier: VIA-3196-02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Plasma concentration of VIA-3196

  0 to 24 hours on Day 1 and Day 14

• Lipid level changes following administration of VIA-3196

  Day 1 to 14

Study Arms (2)

VIA-3196

EXPERIMENTAL

Drug: VIA-3196

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Placebo DRUG

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

Placebo

VIA-3196 DRUG

Oral, daily dosing for 14 days

VIA-3196

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Madrigal Pharmaceuticals, Inc.: lead

Study Sites (1)

PRACS Institute (formerly Cetero Research)

Fargo, North Dakota, 58104, United States

Location

Study Officials

• Rebecca Taub, MD

  Madrigal Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 27, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

US (1)