Drug SafetyPhase 1NCT01367873
Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy Subjects
A Phase 1 study testing VIA-3196 in people with Drug Safety, run by Madrigal Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Safety
- What is being tested?
- VIA-3196
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Drug Safety
- Being tested
- Placebo, VIA-3196
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral, matching number of placebo capsule(s) with active arm
VIA-3196Drug
Also called VIA-3196, Resmetirom
Oral, capsule(s)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Multiple, single-dose, ascending dosing groups (cohorts) will be evaluated. Receives: Drug: Placebo |
| VIA-3196 | Experimental | Multiple, single-dose, ascending dosing groups (cohorts) will be evaluated. Receives: Drug: VIA-3196 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events as a measure of safety and tolerability of VIA-3196
Evaluation will start from predose (Day -1) until the follow-up visit (Day 7 to 11)
Measured: up to 12 days
Secondary outcomes (1)
Plasma concentration of VIA-3196
Assessed with and without food
Measured: 0 to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Taub, MD, Study chair, Madrigal Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367873
- Sponsor's protocol ID
- VIA-3196-01
- Status last verified
- Aug 2023
- First submitted
- 2 Jun 2011
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01367873
- Acronym / sponsor ID
- VIA-3196-01
- Conditions
- Drug Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 7 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMultiple, single-dose, ascending dosing groups (cohorts) will be evaluated. |
| VIA-3196 | Experimental | Drug: VIA-3196Multiple, single-dose, ascending dosing groups (cohorts) will be evaluated. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOral, matching number of placebo capsule(s) with active arm | Drug | Placebo |
| VIA-3196Also: VIA-3196, ResmetiromOral, capsule(s) | Drug | VIA-3196 |
Primary outcome
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)
1 secondary outcome
Plasma concentration of VIA-3196
Time frame: 0 to 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Taub, MD study chair
Madrigal Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VIA-3196 in people with Drug Safety, run by Madrigal Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events as a measure of safety and tolerability of VIA-3196 (time frame: up to 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023; AzTrials last refreshed its copy on 1 Nov 2026.