Clinical Trials Logo
  1. Home
  2. Healthy Adults
  3. NCT06227832

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

Healthy Adults Clinical Trial

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

Clinical Trial Summary

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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06227832
Study type Interventional
Source Kaken Pharmaceutical
Contact
Status Active, not recruiting
Phase Phase 1
Start date December 15, 2023
Completion date July 31, 2024
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04677920 - The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology N/A
Active, not recruiting NCT03312920 - Investigating Memory Retrieval Improvement in Healthy Subjects N/A
Completed NCT03309072 - Investigating Accelerated Learning and Memory in Healthy Subjects Using a Face Name Memory Task N/A
Completed NCT03289832 - Effect of Orally Delivered Phytochemicals on Aging and Inflammation in the Skin N/A
Enrolling by invitation NCT06133530 - Human Milk Oligosaccharides (HMOs) and Gut Microbiota, Immune System in Antarctica N/A
Completed NCT05141903 - Dietary Supplement With and Without a Probiotic and/or Antibiotic
Completed NCT01689259 - Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults Phase 1
Completed NCT01187875 - Resistant Starch and Satiety Phase 0
Completed NCT03312699 - Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort Phase 1
Completed NCT03319134 - Investigating the Neural Correlates in Memory Retrieval After HD-tDCS N/A
Recruiting NCT04104360 - Galacto-oligosaccharides and Intestinal Activity N/A
Completed NCT03228693 - Gene Expression and Biomarker Profiling of Keloid Skin N/A
Completed NCT04146532 - Aspirin Effects on Emotional Reactions Early Phase 1
Completed NCT04206293 - A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers N/A
Recruiting NCT06011018 - Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke N/A
Completed NCT05093205 - STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS Phase 1
Completed NCT04596709 - Investigation of Blood Glucose and Insulin Response After Intake of Vitalose N/A
Completed NCT04272450 - Respiratory Muscle Strength in Different Age Groups
Completed NCT02044679 - Evaluation of Spot Urine as a Biomarker of Fluid Intake in Real Life Conditions N/A
Completed NCT01402973 - Pilot Study of a Dietary Intervention Based Upon Advanced Glycation End Products N/A