Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-KW-6356

Completed · Phase 1

Conditions studied: Healthy Male Subjects

In brief

This is an open-label, single-dose study in healthy male subjects to investigate the absorption, metabolism, and excretion (AME) of KW-6356.

Key facts

Study ID

NCT04147910

Run by

Kyowa Kirin, Inc.

People needed

8

Starts

2019-08-21

Expected to finish

2019-10-02

Last updated by the study team

2024-04-25

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Males, of any race, between 18 and 65 years of age, inclusive.
• Body mass index between 18.0 and 30.0 kg/m2, inclusive.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations.
• Able to sign an ICF and willing to abide by the study restrictions.
• Will agree to use contraception.
• History of at least 1 bowel movement per day.

You may not qualify if…

• Any clinically significant illness as determined by the Principal Investigator.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
• Have received any investigational drug within 30 days or 5.5 half-lives, whichever is longer, prior to study dosing.
• History of drug or alcohol abuse or dependence within 2 years prior to signing of ICF.
• Hospital admission, surgery, within 3 months before investigational product administration.
• Positive hepatitis B surface antigen or hepatitis C RNA, or positive for acquired human immunodeficiency virus.
• Positive urine drug screen for drugs of abuse.
• History of requiring treatment for urinary retention within 3 months before investigational product administration.
• History of seizures.
• Subjects with history of, or active suicidal ideation, or suicide attempt.
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). Subjects with cholecystectomy will not be allowed.
• Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including inducers/inhibitors of CYP3A4 and St. John's wort, within 30 days prior to Day 1.
• Use or intend to use any prescription medications/products within 30 days or 5.5 half-lives (if known), whichever is longer, prior to Check-in.
• Use or intend to use slow-release medications/products considered to still be active within 30 days or 5.5 half-lives (if known), whichever is longer, prior to Check-in.
• Use of any nonprescription medications (for 14 days prior to Check-in).
• Use of tobacco- or nicotine-containing products within 3 months prior to Check-in, or positive cotinine.
• Receipt of blood products within 2 months prior to Check-in.
• Donation of blood (> 200 mL) from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
• Poor peripheral venous access.
• Have previously completed or withdrawn from this study or any other study investigating KW-6356, and have previously received the investigational product.
• Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in.
• Subjects who have participated in a radiolabeled drug study where exposures are known to the Investigator within the previous 4 months prior to admission to the clinic for this study or participated in a radiolabeled drug study where exposures are not known to the Investigator within the previous 6 months prior to admission to the clinic for this study.
• Subjects who, in the opinion of the Investigator, should not participate in this study.

Where it is running

• Covance Clinical Research Unit Inc. — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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