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Completed

NCT Number: NCT01519531

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRACS Institute (formerly Cetero Research)

Fargo, North Dakota, 58104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

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

VIA-3196

Drug

Oral, daily dosing for 14 days

Primary outcomes

  1. Number of Adverse Events as a measure of safety and tolerability of VIA-3196

    Time frame: up to 22 days

    Evaluation will start from predose (Day -1) until the follow-up visit (Day 21)

Secondary outcomes

  1. Plasma concentration of VIA-3196

    Time frame: 0 to 24 hours on Day 1 and Day 14

    Assessed without food

  2. Lipid level changes following administration of VIA-3196

    Time frame: Day 1 to 14

Sponsors and collaborators

Lead sponsor

Madrigal Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2012
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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