Status and phase
Conditions
Treatments
About
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).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
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:
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.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
38 participants in 3 patient groups
Loading...
Central trial contact
Motoki Akamatsu
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal