Clinical trial NCT01367873: Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Safety
Lead sponsor: Madrigal Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Number of Adverse Events as a measure of safety and tolerability of VIA-3196
timeFrame: up to 12 days
Secondary outcomes:
measure: Plasma concentration of VIA-3196
timeFrame: 0 to 72 hours
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Cetero Research
state: North Dakota
Study officials:
affiliation: Madrigal Pharmaceuticals
name: Rebecca Taub, MD
role: STUDY_CHAIR
References: