Healthy Male SubjectsPhase 1NCT04147910
Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-KW-6356
A Phase 1 study testing KW-6356 in people with Healthy Male Subjects, run by Kyowa Kirin, Inc. at 1 site in United States.
Trial summary
This is an open-label, single-dose study in healthy male subjects to investigate the absorption, metabolism, and excretion (AME) of KW-6356. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- KW-6356
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2019to 2 Oct 2019
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-KW-6356 Following a Single Oral Dose in Healthy Male Subjects
This is an open-label, single-dose study in healthy male subjects to investigate the absorption, metabolism, and excretion (AME) of KW-6356.
Read the detailed description
Subjects will be screened to assess their eligibility to enter the study within approximately 4 weeks prior to dose administration. Subjects will be confined to the Clinical Research Unit (CRU) for their entire participation in this study. Eight subjects will be enrolled to allow 6 subjects to complete the study. Each subject will report to the CRU and be confined from Day -1 (the day before dosing) through at least Day 8 (168 hours postdose). A single dose of study drug will be administered on Day 1 (0 hour). On Day 8, subjects can be asked to remain as a resident within the CRU for an additional period to allow for ongoing 24-hour urine, fecal, and blood sample collections. These collections can continue up to a maximum of 336 hours postdose (Day 15). Subjects can be discharged prior to Day 15 if the following individual subject discharge criteria have been satisfied: ≥ 90% of the 14C dose recovered in combined urine and feces, and ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 3 consecutive 24-hour periods in which a fecal sample is provided.
- Conditions
- Healthy Male Subjects
- Being tested
- KW-6356
- Keywords
- Healthy Male Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KW-6356Drug
Single oral dose of KW-6356
| Study group | Role | What they receive |
|---|---|---|
| KW-6356 | Experimental | Single oral dose of carbon-14-KW-6356. Receives: Drug: KW-6356 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed concentration (KW-6356 in plasma and total radioactivity in plasma and blood).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
CL/F
Apparent oral clearance (KW-6356 in plasma).
Measured: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
MRT
Mean residence time (KW-6356 in plasma).
Measured: 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).
Measured: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Aeurine
Cumulative amount excreted in urine (total radioactivity in urine).
Measured: 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).
Measured: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Aefeces
Cumulative amount excreted in feces (total radioactivity in feces).
Measured: 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).
Measured: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Aetotal
Total amount excreted (total radioactivity in urine and feces).
Measured: 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).
Measured: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Metabolic profiling and identification (plasma, urine, and feces).
Measured: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Secondary outcomes (6)
Adverse Events
Number of subjects experiencing an adverse event related to treatment.
Measured: From screening through study completion, an average of 6 weeks.
Severe adverse events.
Number of subjects experiencing a severe adverse event related to treatment.
Measured: From screening through study completion, an average of 6 weeks.
Serum chemistry, hematology, and urinalysis.
Number of subjects with abnormal laboratory values that are related to treatment.
Measured: From screening through study completion, an average of 6 weeks.
Vital signs
Number of subjects with abnormal vital signs that are related to treatment.
Measured: From screening through study completion, an average of 6 weeks.
12-lead ECG.
Number of subjects with abnormal ECG that are related to treatment.
Measured: From screening through study completion, an average of 6 weeks.
Physical examination.
Number of subjects with abnormal physical exam findings that are related to treatment.
Measured: From screening through study completion, an average of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start21 Aug 2019
- Primary completion2 Oct 2019
- Study completion2 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147910
- Sponsor's protocol ID
- 6356-009
- Status last verified
- Apr 2024
- First submitted
- 9 Oct 2019
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-KW-6356 Following a Single Oral Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04147910
- Acronym / sponsor ID
- 6356-009
- Conditions
- Healthy Male Subjects
- Keywords
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Kyowa Kirin, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 2 Oct 2019 (actual)
- First posted
- 1 Nov 2019 (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.
This is an open-label, single-dose study in healthy male subjects to investigate the absorption, metabolism, and excretion (AME) of KW-6356.
Detailed description
Subjects will be screened to assess their eligibility to enter the study within approximately 4 weeks prior to dose administration. Subjects will be confined to the Clinical Research Unit (CRU) for their entire participation in this study. Eight subjects will be enrolled to allow 6 subjects to complete the study. Each subject will report to the CRU and be confined from Day -1 (the day before dosing) through at least Day 8 (168 hours postdose). A single dose of study drug will be administered on Day 1 (0 hour). On Day 8, subjects can be asked to remain as a resident within the CRU for an additional period to allow for ongoing 24-hour urine, fecal, and blood sample collections. These collections can continue up to a maximum of 336 hours postdose (Day 15). Subjects can be discharged prior to Day 15 if the following individual subject discharge criteria have been satisfied: ≥ 90% of the 14C dose recovered in combined urine and feces, and ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 3 consecutive 24-hour periods in which a fecal sample is provided.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KW-6356 | Experimental | Drug: KW-6356Single oral dose of carbon-14-KW-6356. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
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 |
|---|---|---|
| KW-6356Single oral dose of KW-6356 | Drug | KW-6356 |
Primary outcome
Cmax
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Maximum observed concentration (KW-6356 in plasma and total radioactivity in plasma and blood).
tmax
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Time of maximum observed concentration (KW-6356 in plasma and total radioactivity in plasma and blood).
AUC0-t
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
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).
%AUCextra
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Percentage of estimated part for the calculation of AUC0-∞ (KW-6356 in plasma and total radioactivity in plasma and blood).
t1/2
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Elimination half-life (KW-6356 in plasma and total radioactivity in plasma and blood).
kel
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Elimination rate constant (KW-6356 in plasma and total radioactivity in plasma and blood).
Vz/F
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Apparent volume of distribution during terminal phase (KW-6356 in plasma).
CL/F
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Apparent oral clearance (KW-6356 in plasma).
MRT
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Mean residence time (KW-6356 in plasma).
Whole blood/plasma concentration ratio (total radioactivity in blood and plasma).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Aeurine
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Cumulative amount excreted in urine (total radioactivity in urine).
feurine
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Fraction of the dose administered excreted in urine (total radioactivity in urine).
Aefeces
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Cumulative amount excreted in feces (total radioactivity in feces).
fefeces
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Fraction of the dose administered excreted in feces (total radioactivity in feces).
Aetotal
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Total amount excreted (total radioactivity in urine and feces).
fetotal
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Fraction of the dose administered excreted in urine and feces (total radioactivity in urine and feces).
Metabolic profiling and identification (plasma, urine, and feces).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
6 secondary outcomes
Adverse Events
Time frame: From screening through study completion, an average of 6 weeks.
Severe adverse events.
Time frame: From screening through study completion, an average of 6 weeks.
Serum chemistry, hematology, and urinalysis.
Time frame: From screening through study completion, an average of 6 weeks.
Vital signs
Time frame: From screening through study completion, an average of 6 weeks.
12-lead ECG.
Time frame: From screening through study completion, an average of 6 weeks.
Physical examination.
Time frame: From screening through study completion, an average of 6 weeks.
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 25 Apr 2024.
- Individual participant dataSharing planned: No
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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 KW-6356 in people with Healthy Male Subjects, run by Kyowa Kirin, Inc. 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 6 inclusion and 23 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 25 Apr 2024. 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?
Cmax (time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2024.