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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Madrigal Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01367873
First received: June 2, 2011
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Drug Safety
Drug: Placebo
Drug: VIA-3196
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects

Further study details as provided by Madrigal Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Number of Adverse Events as a measure of safety and tolerability of VIA-3196 [ Time Frame: up to 12 days ] [ Designated as safety issue: Yes ]
    Evaluation will start from predose (Day -1) until the follow-up visit (Day 7 to 11)


Secondary Outcome Measures:
  • Plasma concentration of VIA-3196 [ Time Frame: 0 to 72 hours ] [ Designated as safety issue: No ]
    Assessed with and without food


Enrollment: 72
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Oral, matching number of placebo capsule(s) with active arm
Other Name: Placebo
Experimental: VIA-3196
Multiple, single-dose, ascending dosing groups (cohorts) will be evaluated.
Drug: VIA-3196
Oral, capsule(s)
Other Name: VIA-3196
Experimental: VIA-3196 with Food
Second, single dose administered after a standard high-fat breakfast.
Drug: VIA-3196
Oral, capsule(s)
Other Name: VIA-3196
Placebo Comparator: Placebo with Food Drug: Placebo
Oral, matching number of placebo capsule(s) with active arm
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 > 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367873

Locations
United States, North Dakota
Cetero Research
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Madrigal Pharmaceuticals, Inc.
Investigators
Study Chair: Rebecca Taub, MD Madrigal Pharmaceuticals
  More Information

No publications provided

Responsible Party: Madrigal Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01367873     History of Changes
Other Study ID Numbers: VIA-3196-01
Study First Received: June 2, 2011
Last Updated: January 18, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014