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Treatment A: Midazolam 2 mg for Healthy Subjects

Phase 1

Recruiting

Research Sponsored by Takeda

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 period 1-midazolam alone: day 1 predose up to 24 hours (h) postdose; repaglinide alone: day 2 predose up to 16 h postdose; period 2-midazolam, with tak-279: day 14 predose up to 24 h postdose; repaglinide with tak-279:day 15 predose up to 16 h postdose

Awards & highlights

Study Summary

This trial aims to understand how different doses of TAK-279 impact the bodies of healthy adults and how it interacts with midazolam and repaglinide. The study also seeks to evaluate

Who is the study for?

This trial is for healthy adults who can stay at the clinic for 19 days. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.Check my eligibility

What is being tested?

The study is testing how TAK-279 affects the body's handling of two drugs, midazolam and repaglinide, when taken orally. It aims to understand TAK-279's pharmacokinetics (PK) - how it's absorbed, distributed, metabolized, and excreted in humans.See study design

What are the potential side effects?

Potential side effects of TAK-279 aren't detailed but may include reactions typical of clinical trials such as nausea, headache, dizziness or other responses that will be monitored through blood tests and participant observation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ period 1-midazolam alone: day 1 predose up to 24 hours (h) postdose; repaglinide alone: day 2 predose up to 16 h postdose; period 2-midazolam, with tak-279: day 14 predose up to 24 h postdose; repaglinide with tak-279:day 15 predose up to 16 h postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~period 1-midazolam alone: day 1 predose up to 24 hours (h) postdose; repaglinide alone: day 2 predose up to 16 h postdose; period 2-midazolam, with tak-279: day 14 predose up to 24 h postdose; repaglinide with tak-279:day 15 predose up to 16 h postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and period 1-midazolam alone: day 1 predose up to 24 hours (h) postdose; repaglinide alone: day 2 predose up to 16 h postdose; period 2-midazolam, with tak-279: day 14 predose up to 24 h postdose; repaglinide with tak-279:day 15 predose up to 16 h postdose for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam and Repaglinide When Administered Alone and With TAK-279

Cmax: Maximum Observed Plasma Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279

Secondary outcome measures

Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI)

Trial Design

4Treatment groups

Experimental Treatment

Group I: Treatment C + Treatment B: TAK-279 Dose 1 + Repaglinide 0.5 mgExperimental Treatment2 Interventions

TAK-279 Dose 1, capsules, orally, on Days 1 through 15 of Period 2 followed by Repaglinide 0.5 mg (1*0.5 mg), tablets, orally, on Day 15 of Period 2.

Group II: Treatment C + Treatment A: TAK-279 Dose 1 + Midazolam 2 mgExperimental Treatment2 Interventions

TAK-279 Dose 1, capsules, orally, on Days 1 through 15 of Period 2 followed by Midazolam 2 mg (1 mL of 2 mg/mL), syrup, orally, on Day 14 of Period 2.

Group III: Treatment B: Repaglinide 0.5 mgExperimental Treatment1 Intervention

Repaglinide 0.5 mg (1*0.5 mg), tablets, orally, on Day 2 of Period 1.

Group IV: Treatment A: Midazolam 2 mgExperimental Treatment1 Intervention

Midazolam 2 mg (1 milliliter [mL] of 2 milligram per milliliter [mg/mL]), syrup, orally, on Day 1 of Period 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Repaglinide

2016

Completed Phase 4

~7040

Midazolam

2018

Completed Phase 4

~1910

TAK-279

2023

Completed Phase 1

~180

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?

TakedaLead Sponsor

1,206 Previous Clinical Trials

4,188,049 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,215 Previous Clinical Trials

499,594 Total Patients Enrolled

Frequently Asked Questions

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

Am I eligible to partake in this clinical investigation?

"To qualify for this research study, individuals must be deemed healthy and fall between the ages of 18 to 55 years. A total of 20 volunteers are sought for participation in this investigation."

Answered by AI

Does this medical study accept participants who are aged 60 and above?

"To be considered eligible for participation, individuals between 18 and 55 years of age are sought. Notably, there are currently 66 trials targeted at those below 18 and a further 373 aimed at individuals older than 65."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"According to details provided on clinicaltrials.gov, the ongoing trial is not actively seeking participants. Initially listed on 3/26/2024 and last revised on 3/1/2024, this study is presently closed for recruitment. However, among the multitude of trials available, there are currently 802 studies that welcome patient enrollment."

Answered by AI

What is the safety profile of administering Midazolam 2 mg as Treatment A in individuals?

"Based on being a Phase 1 trial, Treatment A: Midazolam 2 mg has been assigned a safety rating of 1 by our team at Power due to the scarcity of data supporting its safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults

2024. "A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06290050.

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