Drug SafetyPhase 1NCT01519531
Ascending Multiple-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 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. 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
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Nov 2012
- 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 ≥ 110mg/dL.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
PRACS Institute (formerly Cetero Research)
Fargo, North Dakota, 58104
About this study
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
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.
- 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, daily-dosing for 14 days; matching number of placebo capsule(s) with active arm
VIA-3196Drug
Oral, daily dosing for 14 days
| Study group | Role | What they receive |
|---|---|---|
| VIA-3196 | Experimental | Not described Receives: Drug: VIA-3196 |
| Placebo | Placebo comparator | Multiple, ascending dosing groups (cohorts) will be evaluated. Receives: Drug: Placebo |
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 21)
Measured: up to 22 days
Secondary outcomes (2)
Plasma concentration of VIA-3196
Assessed without food
Measured: 0 to 24 hours on Day 1 and Day 14
Lipid level changes following administration of VIA-3196
Measured: Day 1 to 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2012
- Study completionNov 2012
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Taub, MD, Study director, Madrigal Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519531
- Sponsor's protocol ID
- VIA-3196-02
- Status last verified
- Dec 2012
- First submitted
- 24 Jan 2012
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01519531
- Acronym / sponsor ID
- VIA-3196-02
- Conditions
- Drug Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 27 Jan 2012 (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 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.
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 |
|---|---|---|
| VIA-3196 | Experimental | Drug: VIA-3196 |
| Placebo | Placebo comparator | Drug: PlaceboMultiple, 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 (5 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 ≥ 110mg/dL.
Key exclusion criteria (10 listed)
- 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.
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, daily-dosing for 14 days; matching number of placebo capsule(s) with active arm | Drug | Placebo |
| VIA-3196Oral, daily dosing for 14 days | Drug | VIA-3196 |
Primary outcome
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)
2 secondary outcomes
Plasma concentration of VIA-3196
Time frame: 0 to 24 hours on Day 1 and Day 14
Lipid level changes following administration of VIA-3196
Time frame: Day 1 to 14
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 6 Dec 2012.
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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 director
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 5 inclusion and 10 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 6 Dec 2012. 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 22 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 6 Dec 2012; AzTrials last refreshed its copy on 3 Nov 2026.