Ascending Multiple-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:
NCT01519531
First received: January 24, 2012
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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.


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 Multiple-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 22 days ] [ Designated as safety issue: Yes ]
    Evaluation will start from predose (Day -1) until the follow-up visit (Day 21)


Secondary Outcome Measures:
  • Plasma concentration of VIA-3196 [ Time Frame: 0 to 24 hours on Day 1 and Day 14 ] [ Designated as safety issue: No ]
    Assessed without food

  • Lipid level changes following administration of VIA-3196 [ Time Frame: Day 1 to 14 ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VIA-3196 Drug: VIA-3196
Oral, daily dosing for 14 days
Other Name: VIA-3196
Placebo Comparator: Placebo
Multiple, ascending dosing groups (cohorts) will be evaluated.
Drug: Placebo
Oral, daily-dosing for 14 days; 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 ≥ 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.
  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: NCT01519531

Locations
United States, North Dakota
PRACS Institute (formerly Cetero Research)
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Madrigal Pharmaceuticals, Inc.
Investigators
Study Director: Rebecca Taub, MD Madrigal Pharmaceuticals
  More Information

No publications provided

Responsible Party: Madrigal Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01519531     History of Changes
Other Study ID Numbers: VIA-3196-02
Study First Received: January 24, 2012
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014