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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01367873
First Posted: June 7, 2011
Last Update Posted: January 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Madrigal Pharmaceuticals, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
    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
Experimental: VIA-3196
Multiple, single-dose, ascending dosing groups (cohorts) will be evaluated.
Drug: VIA-3196
Oral, capsule(s)
Experimental: VIA-3196 with Food
Second, single dose administered after a standard high-fat breakfast.
Drug: VIA-3196
Oral, capsule(s)
Placebo Comparator: Placebo with Food Drug: Placebo
Oral, matching number of placebo capsule(s) with active arm

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Madrigal Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01367873     History of Changes
Other Study ID Numbers: VIA-3196-01
First Submitted: June 2, 2011
First Posted: June 7, 2011
Last Update Posted: January 19, 2012
Last Verified: January 2012