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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01367873 |
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Date of registration:
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02/06/2011 |
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Primary sponsor: |
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Public title:
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Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy Subjects
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Scientific title:
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A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01367873 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Rebecca Taub, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Madrigal Pharmaceuticals |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Drug Safety
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Intervention(s)
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Drug: Placebo
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Drug: VIA-3196
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Primary Outcome(s)
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Number of Adverse Events as a measure of safety and tolerability of VIA-3196
[Time Frame: up to 12 days]
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Secondary Outcome(s)
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Plasma concentration of VIA-3196
[Time Frame: 0 to 72 hours]
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Secondary ID(s)
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VIA-3196-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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