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Sequence CAB for Healthy Adult Subjects

Phase 1

Waitlist Available

Led By Michelle Valentine, DO

Research Sponsored by Biogen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 1 of each period, which is 14 days for both treatment a and treatment b and 4 days for treatment c

Awards & highlights

Study Summary

This trial is studying the effect of a drug (omaveloxolone) on the heart rate of healthy people. It'll be tested vs. placebo and another drug (moxifloxacin). All treatments will be given after a high-fat meal. C-QTc analysis is the primary focus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 1 of each period, which is 14 days for both treatment a and treatment b and 4 days for treatment c

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 1 of each period, which is 14 days for both treatment a and treatment b and 4 days for treatment c

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 1 of each period, which is 14 days for both treatment a and treatment b and 4 days for treatment c for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in placebo-corrected QTcF (∆∆QTcF)

Trial Design

6Treatment groups

Experimental Treatment

Group I: Sequence CBAExperimental Treatment2 Interventions

Subjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment C (Period 1 from Day 1 - 4), Treatment B (Period 2 from Day 4 - 18), and Treatment A (Period 3 from Day 18 - 32)

Group II: Sequence CABExperimental Treatment2 Interventions

Subjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment C (Period 1 from Day 1 - 4), Treatment A (Period 2 from Day 4 - 18), and Treatment B (Period 3 from Day 18 - 32)

Group III: Sequence BCAExperimental Treatment2 Interventions

Subjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment B (Period 1 from Day 1 - 15), Treatment C (Period 2 from Day 15 to 18), and Treatment A (Period 3 from Day 18 - 32)

Group IV: Sequence BACExperimental Treatment2 Interventions

Subjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo 450 mg and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment B (Period 1 from Day 1-15), Treatment A (Period 2 from Day 15 - 29, and Treatment C (Period 3 from Day 29 to 32)

Group V: Sequence ACBExperimental Treatment2 Interventions

Subjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo 450 mg and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment A (Period 1 from Day 1-15), Treatment C (Period 2 from Day 15 -18), and Treatment B (Period 3from Day 18 - 32)

Group VI: Sequence ABCExperimental Treatment2 Interventions

Subjects receive three treatments (A: omaveloxolone 450 mg, B: omaveloxolone matching placebo 450 mg and C: moxifloxacin 400 mg) administered in a single dose with the standard FDA high-fat meal in three periods. Treatment A (Period 1 from Day 1 - 15), Treatment B (Period 2 from Day 15 - 29), and Treatment C(Period 3 from Day 29 -32)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omaveloxolone

2019

Completed Phase 1

~120

Moxifloxacin

2013

Completed Phase 4

~3290

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BiogenLead Sponsor

639 Previous Clinical Trials

467,406 Total Patients Enrolled

3 Trials studying Healthy Adult Subjects

178 Patients Enrolled for Healthy Adult Subjects

Reata, a wholly owned subsidiary of BiogenLead Sponsor

45 Previous Clinical Trials

6,380 Total Patients Enrolled

2 Trials studying Healthy Adult Subjects

81 Patients Enrolled for Healthy Adult Subjects

Q2 SolutionsIndustry Sponsor

13 Previous Clinical Trials

1,128 Total Patients Enrolled

1 Trials studying Healthy Adult Subjects

20 Patients Enrolled for Healthy Adult Subjects

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the Sequence CBA protocol sanctioned by the Food and Drug Administration?

"Sequence CBA's safety was given a score of 1 on the scale due to its Phase 1 status, meaning there is scarce evidence confirming its efficacy and safety."

Answered by AI

Is there an age restriction for participants in this medical experiment?

"The age requirements for this clinical trial are between 18 and 55 years old, as described in the eligibility criteria."

Answered by AI

Are there vacancies available for potential participants in this experiment?

"Clinicaltrials.gov displays that this research trial is presently in search of participants, with the first advertisement posted on July 11th 2023 and last updated on August 9th 2023."

Answered by AI

Might I qualify for this clinical investigation?

"This research project is accepting 30 individuals between 18-55 years old that meet the following prerequisites: Healthy males and/or females, BMI of 18.0 to 32.0 kg/m2 (inclusive), Non-pregnant or lactating women of childbearing potential, Males must use contraception during trial period., Comprehending ICF documents and agreeable with study restrictions."

Answered by AI

What is the current enrollment for this clinical experiment?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this trial initiated on July 11th 2023, is actively searching for participants across one location and requires thirty individuals in total to complete the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A TQTc Study for Omaveloxolone

2023. "A TQTc Study for Omaveloxolone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05927649.