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KP-001/Metformin for Healthy Adults

Phase 1

Waitlist Available

Research Sponsored by Kaken Pharmaceutical

Eligibility Criteria Checklist

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

Must have

Participants who are male or female, 18-55 years of age, inclusive, at screening.

Participant is a continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to Day -1 of Treatment Period 1 and throughout the study, based on participant self-reporting and the result of cotinine test at screening and/or Day -1 of Treatment Period.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

Study Summary

This trial aims to study the effects of a drug called KP-001 on the way another drug called Metformin is processed in the body, as well as its effects on a drug called Midaz

Who is the study for?

Healthy adults aged 18-55, non-smokers for at least 3 months, with normal medical screening results. Women must be of non-childbearing potential or use contraception; men must agree to use a condom and spermicide. Excludes those with significant health issues, recent drug/alcohol abuse, certain medication usage within specific time frames, major illness/surgery recently, or employees of the study's sponsor.Check my eligibility

What is being tested?

The trial is testing KP-001's effects on how the body processes Metformin and Midazolam and how Clarithromycin affects KP-001. Participants will stay in-house for up to two weeks during one of three parts of the study to evaluate safety and tolerability.See study design

What are the potential side effects?

While not specified here, common side effects may include reactions at the injection site, nausea, headache, fatigue. Since participants are healthy volunteers monitored in a clinical setting any unexpected side effect would be promptly addressed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

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I haven't smoked or used nicotine products for at least 3 months.

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My weight is at least 50 kg and my BMI is between 18 and 30.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

PK parameters of KP-001 in plasma: AUCinf

PK parameters of KP-001 in plasma: Cmax

PK parameters of metformin in plasma: Maximum observed concentration (Cmax)

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: KP-001/MidazolamExperimental Treatment2 Interventions

Group II: KP-001/MetforminExperimental Treatment2 Interventions

Group III: KP-001/ClarithromycinExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Clarithromycin

2017

Completed Phase 4

~3950

Midazolam

2018

Completed Phase 4

~1910

Metformin

2006

Completed Phase 4

~2430

0 / 3Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Kaken PharmaceuticalLead Sponsor

5 Previous Clinical Trials

769 Total Patients Enrolled

Frequently Asked Questions

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

Which specific criteria must individuals meet in order to be eligible for participation in this research study?

"To meet the eligibility criteria for this investigation, potential participants must be healthy adults aged between 18 and 55. The trial aims to recruit approximately 36 individuals."

Answered by AI

Are there any available slots for patients to participate in this research study?

"Indeed, the information provided on clinicaltrials.gov indicates that this study is actively seeking eligible participants. The initial posting of the trial occurred on December 15th, 2023 and it was last updated on January 26th, 2024. Currently, there is a need to recruit a total of 36 patients from one designated location."

Answered by AI

What is the current number of individuals actively involved in this medical study?

"Indeed, the information available on clinicaltrials.gov confirms that this study is actively seeking eligible participants. The initial posting date for this trial was December 15th, 2023 and it was last updated on January 26th, 2024. A total of 36 patients will be enrolled from a single location."

Answered by AI

Has KP-001/Metformin received official approval from the FDA?

"Our team at Power has assigned a safety rating of 1 to KP-001/Metformin based on the fact that this is a Phase 1 trial, indicating limited available data regarding both safety and efficacy."

Answered by AI

Does the study encompass recruitment of individuals who have surpassed their eightieth year?

"For this particular clinical trial, individuals aged 18 to 55 are eligible for enrollment based on the provided inclusion criteria. It is worth noting that there is a separate clinical trial available specifically for patients under the age of 18, and another set of ten trials catering to patients over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Determine the Effect of KP-001 on Metformin and Midazolam Pharmacokinetics and the Effect of Clarithromycin on KP-001 Pharmacokinetics in Healthy Adult Participants

2023. "A Study to Determine the Effect of KP-001 on Metformin and Midazolam Pharmacokinetics and the Effect of Clarithromycin on KP-001 Pharmacokinetics in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06227832.

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