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

NCT04147910 | Completed Phase 1 FDA Drug

• 1 other identifier: 6356-009
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Male Subjects

Keywords

Healthy Male Subjects

Outcome Measures

Primary Outcomes (17)

• Cmax

  Maximum observed concentration (KW-6356 in plasma and total radioactivity in plasma and blood).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• tmax

  Time of maximum observed concentration (KW-6356 in plasma and total radioactivity in plasma and blood).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• AUC0-t

  Area under the drug concentration-time curve from time zero to the last quantifiable concentration (KW-6356 in plasma and total radioactivity in plasma and blood).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• %AUCextra

  Percentage of estimated part for the calculation of AUC0-∞ (KW-6356 in plasma and total radioactivity in plasma and blood).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• t1/2

  Elimination half-life (KW-6356 in plasma and total radioactivity in plasma and blood).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• kel

  Elimination rate constant (KW-6356 in plasma and total radioactivity in plasma and blood).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• Vz/F

  Apparent volume of distribution during terminal phase (KW-6356 in plasma).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• CL/F

  Apparent oral clearance (KW-6356 in plasma).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• MRT

  Mean residence time (KW-6356 in plasma).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• Whole blood/plasma concentration ratio (total radioactivity in blood and plasma).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• Aeurine

  Cumulative amount excreted in urine (total radioactivity in urine).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• feurine

  Fraction of the dose administered excreted in urine (total radioactivity in urine).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• Aefeces

  Cumulative amount excreted in feces (total radioactivity in feces).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• fefeces

  Fraction of the dose administered excreted in feces (total radioactivity in feces).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• Aetotal

  Total amount excreted (total radioactivity in urine and feces).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• fetotal

  Fraction of the dose administered excreted in urine and feces (total radioactivity in urine and feces).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

• Metabolic profiling and identification (plasma, urine, and feces).

  Pre-dose up to 168 hours post dose, up to 336 hours post dose.

Secondary Outcomes (6)

• Adverse Events

  From screening through study completion, an average of 6 weeks.

• Severe adverse events.

  From screening through study completion, an average of 6 weeks.

• Serum chemistry, hematology, and urinalysis.

  From screening through study completion, an average of 6 weeks.

• Vital signs

  From screening through study completion, an average of 6 weeks.

• 12-lead ECG.

  From screening through study completion, an average of 6 weeks.

Study Arms (1)

KW-6356

EXPERIMENTAL

Single oral dose of carbon-14-KW-6356.

Drug: KW-6356

Interventions

KW-6356 DRUG

Single oral dose of KW-6356

KW-6356

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Kyowa Kirin, Inc.: lead

Study Sites (1)

Covance Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: November 1, 2019
• Study Start: August 21, 2019
• Primary Completion: October 2, 2019
• Study Completion: October 2, 2019
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)