Healthy AdultsPhase 1NCT06227832

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

A Phase 1 study testing KP-001, Metformin and Midazolam in people with Healthy Adults, run by Kaken Pharmaceutical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Adults
What is being tested?: KP-001, Metformin and Midazolam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: 15 Dec 2023to 31 Jul 2024
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

Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the Screening Visit procedures.
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.
Participant is medically healthy with no clinically significant abnormal screening results (e.g., medical history, physical examination, laboratory profiles, vital signs, or ECGs), in the opinion of the Investigator or designee. If screening and/or admission results are abnormal, they may be repeated once at screening and/or once at admission to confirm the participant's eligibility.
Participant has body weight ≥ 50.0 kg and BMI within the range 18.0 to 30.0 kg/m2 (inclusive) at screening.
Participant is a woman of non-childbearing potential who:

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Is postmenopausal with amenorrhea for at least 1 year prior to screening and with follicle-stimulating hormone (FSH) of 40 IU/L or higher.
OR
Has undergone one of the following:
bilateral tubal ligation or bilateral salpingectomy
hysterectomy
bilateral oophorectomy
Male participant who is sexually active with female partner(s) of childbearing potential must agree to use both a condom and spermicide from the first dose until 91 days after the last dose of KP-001.
Male participant must agree not to donate sperm from the first dose until 91 days after the last dose of KP-001.

Who cannot join

Participant is Japanese, Korean or Chinese descent.
Participant is legally, mentally or physically incapacitated or, in the opinion of the Investigator, has significant mental or emotional problems, including psychiatric illness (e.g., depression and/or anxiety) at the time of the Screening Visit, or that could reasonably be expected to develop during the conduct of the study.
Participant has a significant history or clinical manifestation of any metabolic, allergic, dermatologic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder as determined by the Investigator or designee.
Participant has a history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
Participant used any prescription or non-prescription medications (including vitamins, recreational drugs, and dietary or herbal supplements) within 14 days or 5 half-lives (whichever is longer) prior to Day -1 of Treatment Period 1 and until completion of the Follow-up visit unless, in the opinion of the Investigator, may be treatment for an adverse event (AE) or will not interfere with the interpretation of safety.
Participant underwent blood donation or transfusion within 56 days prior to Day -1 of Treatment Period 1.

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Participant has a history or presence of hypersensitivity or idiosyncratic reaction to any components of the KP-001 formulation or any components of formulation used as study intervention during the study.
Participant has a history of drug or alcohol abuse [regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of hard liquor) within one year before the Screening Visit.
Participant has a complication of drug allergies or history of drug allergies.
Female participant has a positive pregnancy test or is lactating.
Participant used any investigational drug in the last 30 days or 5 half-lives (if known), whichever is longer, prior to Day -1 of Treatment Period 1.
Participant had any major illness within 30 days before the Screening Visit.
Participant had any major surgical procedure within 30 days prior to Day -1 of Treatment Period 1 or any planned surgery during study period.
Participant had any laboratory abnormality that, in the judgment of the Investigator, would put the participant at unacceptable risk for participation in the study or may interfere with the assessments included in the study.
Participant has abnormal findings on the screening ECG deemed clinically significant by the Investigator or qualified designee.
Participant is an employee of the Sponsor or any contract research organization (CRO) involved in the study, the Investigator, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee involved in the study.
Participant has consumed alcohol- or caffeine-containing foods and beverages within 72 hours prior to Day -1 of Treatment Period 1 and does not agree to refrain from consuming during the entire study, unless deemed acceptable by the Investigator.
Participant has positive urine drug or urine alcohol and positive cotinine test results at Screening or Day -1 of Treatment Period 1.
Participant has consumed grapefruit-containing foods and beverages within 7 days prior to Day -1 of Treatment Period 1 and does not agree to refrain from consuming during the entire study.
Participant has consumed St. John's wort-containing foods and beverages within 14 days prior to Day -1 of Treatment Period 1 and does not agree to refrain from consuming during the entire study.
Participant is unable or unwilling to undergo multiple venipunctures.
Participant has a history or presence of liver disease or cholecystectomy within one year prior to screening.
Participant has an HbA1c >5.7% at Screening.
Participant has positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBcAb), hepatitis B core antibody (HBsAg) or hepatitis C virus (HCV).
Participant has a disorder or any condition that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
Participant has an estimated creatinine clearance calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula <80 mL/min at Screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

Parexel Early Phase Clinical Unit - Los Angeles
Glendale, California, 91206

Other trials in United States

About this study

Official title: An Open-label Study to Determine the Effect of Oral Doses of KP-001 on Metformin and Midazolam Pharmacokinetics After a Single Oral Administration and to Determine the Effect of Clarithromycin on KP-001 Pharmacokinetics After a Single Oral Administration in Healthy Adult Participants

The purpose of this study is to determine the Effects of KP-001 on Metformin (a substrate of MATE1) and Midazolam (a substrate of CYP3A4) Pharmacokinetics and the Effect of Clarithromycin (potent CYP3A4/P-gp Inhibitor) on KP-001 Pharmacokinetics in Healthy Adult Participants. The study will also evaluate the safety and tolerability of KP-001 with and without a single dose or multiple doses of an interaction drug. The study comprises 3 parts. Participants will stay in the Clinical Unit during the study, depending on which part they assigned to. Participants will remain at the clinical site for a 13 day/12 night in-house stay (Part 1), a 14 day/13 night in house stay (Part 2), or a 11 day/10 night in-house stay (Part 3).

Conditions: Healthy Adults
Being tested: KP-001, Metformin, Midazolam, Clarithromycin
Keywords: Phase 1, Drug-drug interaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KP-001Drug
KP-001
MetforminDrug
oral dose of 850 mg Metformin
MidazolamDrug
oral dose of 2 mg Midazolam
ClarithromycinDrug
oral doses of 1000 mg Clarithromycin

Study groups in NCT06227832
Study group	Role	What they receive
KP-001/Metformin	Experimental	Not described Receives: Drug: KP-001; Drug: Metformin
KP-001/Midazolam	Experimental	Not described Receives: Drug: KP-001; Drug: Midazolam
KP-001/Clarithromycin	Experimental	Not described Receives: Drug: KP-001; Drug: Clarithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic (PK) parameters of metformin in plasma: Area under the concentration-time curve from time 0 extrapolated to infinite time (AUCinf)
To assess the effect of repeated doses of KP-001, an inhibitor of organic cation transporter 2 (OCT2) and multidrug and toxin extrusion protein 1 (MATE-1), on the PK of a single dose of metformin in healthy adult, non-east Asian participants in the United States.
Measured: 13 days
PK parameters of midazolam in plasma: AUCinf
To assess the effect of repeated dose of KP-001, an inducer of CYP3A4, on the PK of a single dose of midazolam in healthy adult, non-east Asian participants in the United States.
Measured: 14 days
PK parameters of KP-001 in plasma: AUCinf
To compare the PK of KP-001 administered alone as a single dose and in combination with clarithromycin, an inhibitor of CYP3A4 and P-gp, in healthy adult, non-east Asian participants in the United States.
Measured: 11 days
PK parameters of metformin in plasma: Maximum observed concentration (Cmax)
To assess the effect of repeated doses of KP-001, an inhibitor of organic cation transporter 2 (OCT2) and multidrug and toxin extrusion protein 1 (MATE-1), on the PK of a single dose of metformin in healthy adult, non-east Asian participants in the United States.
Measured: 13 days
PK parameters of midazolam in plasma: Cmax
To assess the effect of repeated dose of KP-001, an inducer of CYP3A4, on the PK of a single dose of midazolam in healthy adult, non-east Asian participants in the United States.
Measured: 14 days
PK parameters of KP-001 in plasma: Cmax
To compare the PK of KP-001 administered alone as a single dose and in combination with clarithromycin, an inhibitor of CYP3A4 and P-gp, in healthy adult, non-east Asian participants in the United States.
Measured: 11 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 202331 Jul 2024

First posted29 Jan 2024
Study start15 Dec 2023
Primary completion15 Mar 2024
Study completion31 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy AdultsStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06227832
Sponsor's protocol ID: KP-001-102
Status last verified: Mar 2024
First submitted: 17 Jan 2024
Last updated: 7 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study to Determine the Effect of Oral Doses of KP-001 on Metformin and Midazolam Pharmacokinetics After a Single Oral Administration and to Determine the Effect of Clarithromycin on KP-001 Pharmacokinetics After a Single Oral Administration in Healthy Adult Participants
ClinicalTrials.gov ID: NCT06227832
Acronym / sponsor ID: KP-001-102
Conditions: Healthy Adults
Keywords: Phase 1, Drug-drug interaction
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Kaken PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 15 Dec 2023 (actual)
Primary completion: 15 Mar 2024 (actual)
Study completion: 31 Jul 2024 (actual)
First posted: 29 Jan 2024 (actual)
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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
KP-001/Metformin	Experimental	Drug: KP-001, Drug: Metformin
KP-001/Midazolam	Experimental	Drug: KP-001, Drug: Midazolam
KP-001/Clarithromycin	Experimental	Drug: KP-001, Drug: Clarithromycin

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the Screening Visit procedures.
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.
Participant is medically healthy with no clinically significant abnormal screening results (e.g., medical history, physical examination, laboratory profiles, vital signs, or ECGs), in the opinion of the Investigator or designee. If screening and/or admission results are abnormal, they may be repeated once at screening and/or once at admission to confirm the participant's eligibility.
Participant has body weight ≥ 50.0 kg and BMI within the range 18.0 to 30.0 kg/m2 (inclusive) at screening.

Key exclusion criteria (26 listed)

Participant is Japanese, Korean or Chinese descent.
Participant is legally, mentally or physically incapacitated or, in the opinion of the Investigator, has significant mental or emotional problems, including psychiatric illness (e.g., depression and/or anxiety) at the time of the Screening Visit, or that could reasonably be expected to develop during the conduct of the study.
Participant has a significant history or clinical manifestation of any metabolic, allergic, dermatologic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder as determined by the Investigator or designee.
Participant has a history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
Participant used any prescription or non-prescription medications (including vitamins, recreational drugs, and dietary or herbal supplements) within 14 days or 5 half-lives (whichever is longer) prior to Day -1 of Treatment Period 1 and until completion of the Follow-up visit unless, in the opinion of the Investigator, may be treatment for an adverse event (AE) or will not interfere with the interpretation of safety.

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
KP-001KP-001	Drug	KP-001/Clarithromycin, KP-001/Metformin, KP-001/Midazolam
Metforminoral dose of 850 mg Metformin	Drug	KP-001/Metformin
Midazolamoral dose of 2 mg Midazolam	Drug	KP-001/Midazolam
Clarithromycinoral doses of 1000 mg Clarithromycin	Drug	KP-001/Clarithromycin

Primary outcome

Pharmacokinetic (PK) parameters of metformin in plasma: Area under the concentration-time curve from time 0 extrapolated to infinite time (AUCinf)
Time frame: 13 days
To assess the effect of repeated doses of KP-001, an inhibitor of organic cation transporter 2 (OCT2) and multidrug and toxin extrusion protein 1 (MATE-1), on the PK of a single dose of metformin in healthy adult, non-east Asian participants in the United States.
PK parameters of midazolam in plasma: AUCinf
Time frame: 14 days
To assess the effect of repeated dose of KP-001, an inducer of CYP3A4, on the PK of a single dose of midazolam in healthy adult, non-east Asian participants in the United States.
PK parameters of KP-001 in plasma: AUCinf
Time frame: 11 days
To compare the PK of KP-001 administered alone as a single dose and in combination with clarithromycin, an inhibitor of CYP3A4 and P-gp, in healthy adult, non-east Asian participants in the United States.
PK parameters of metformin in plasma: Maximum observed concentration (Cmax)
Time frame: 13 days
To assess the effect of repeated doses of KP-001, an inhibitor of organic cation transporter 2 (OCT2) and multidrug and toxin extrusion protein 1 (MATE-1), on the PK of a single dose of metformin in healthy adult, non-east Asian participants in the United States.
PK parameters of midazolam in plasma: Cmax
Time frame: 14 days
To assess the effect of repeated dose of KP-001, an inducer of CYP3A4, on the PK of a single dose of midazolam in healthy adult, non-east Asian participants in the United States.
PK parameters of KP-001 in plasma: Cmax
Time frame: 11 days
To compare the PK of KP-001 administered alone as a single dose and in combination with clarithromycin, an inhibitor of CYP3A4 and P-gp, in healthy adult, non-east Asian participants in the United States.

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 7 Mar 2025.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 KP-001, Metformin and Midazolam in people with Healthy Adults, run by Kaken Pharmaceutical 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 14 inclusion and 26 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 7 Mar 2025. 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. 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?

Pharmacokinetic (PK) parameters of metformin in plasma: Area under the concentration-time curve from time 0 extrapolated to infinite time (AUCinf) (time frame: 13 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06227832.

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 7 Mar 2025.