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CompletedNCT02878096Updated Oct 14, 2016

Bioavailability of [14C]-SK-1404 ADME & IV Microtracer Study

A Phase 1 interventional study of [14C]-SK-1404 in Nocturia, sponsored by Sanwa Kagaku Kenkyusho Co., Ltd.. Completed at 1 site in United Kingdom. Open to male participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-14.

Sponsored by Sanwa Kagaku Kenkyusho Co., Ltd. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
30 Years to 65 Years
Sex
Male
01

Study summary

The primary objectives of the study are:

  • To determine the absolute bioavailability of SK-1404
  • To assess the mass balance recovery after a single oral (PO) dose of carbon-14 (14C)-SK-1404
  • To provide plasma, urine and faecal samples for metabolite profiling and structural identification

The secondary objectives of the study are:

  • To determine the routes and rates of elimination of [14C]-SK-1404
  • To identify the chemical structure of each metabolite with an exposure (AUC) of more than 10% of circulating total radioactivity
  • To explore the intravenous (IV) pharmacokinetics (PK) of [14C]-SK-1404
  • To further explore the PO PK of SK-1404
  • To provide additional safety and tolerability information for SK-1404
Read the detailed description

This is a single-centre, 2-part, open-label, non-randomised, sequential, single dose study in healthy male subjects. It is planned to enrol a single cohort of 6 healthy male subjects who will participate in Parts 1 and Part 2 of the study.

In Part 1, each subject will receive a single PO dose of SK-1404 followed by an IV microtracer dose of [14C]-SK-1404.

In Part 2, each subject will receive a single PO dose of [14C]-SK-1404.

02

Conditions studied

  • Nocturia

Browse trials for

Keywords

  • nocturnal polyuria
03

In context

Nocturia

124 studies on the registry are indexed under Nocturia; 24 are open to participants now.

This study's enrollment of 6 is below the median of 67 across 94 interventional studies indexed under Nocturia.

Browse Nocturia studies →

Lead sponsor

Sanwa Kagaku Kenkyusho Co., Ltd. is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy males
  2. Age 30 to 65 years of age
  3. Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
  4. Must be willing and able to communicate and participate in the whole study
  5. Must provide written informed consent
  6. Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
  7. Must agree to use an adequate method of contraception

Exclusion criteria

Exclusion Criteria:

  1. Males with pregnant partners
  2. Participation in a clinical research study within the 3 months prior to IMP dose
  3. Subjects who are study site employees, or immediate family members of a study site or sponsor employee
  4. Subjects who have previously been enrolled in this study
  5. Subjects who have previously been dosed with SK-1404
  6. History of any drug or alcohol abuse in the past 2 years
  7. Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine) in the past year
  8. Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement products. A breath carbon monoxide reading of greater than 10 ppm at screening or admission
  9. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
  10. Subjects who have been enrolled in an ADME study in the last 12 months
  11. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
  12. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1)
  13. Aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase >1.5 × upper limit of normal confirmed by repeat testing
  14. Serum sodium below the lower limit of normal
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    [14C]-SK-1404

    Drug: [14C]-SK-1404

Interventions

  • Drug[14C]-SK-1404

    In Part 1, each subject will receive a single PO dose of SK-1404 followed by an IV microtracer dose of \[14C\]-SK-1404.

06

What researchers measure

Primary outcomes

  1. Absolute bioavailability (F) calculated with the AUC values of IV administration in Part 1 and PO administration in Part 2

    Time frame: Predose to 96hr

  2. Mass balance recovery of total radioactivity in urine, faeces and all excreta

    Amount excreted (Ae), and Ae as a percentage of the administered dose (%Ae), cumulative recovery (Cum Ae) and cumulative recovery expressed as a percentage of the dose (Cum %Ae)

    Time frame: Predose to 168hr

  3. Number and structural identification of known and unknown metabolites of SK-1404 in the plasma, urine and faeces samples

    Time frame: Predose to 168hr

Secondary outcomes

  1. Ae total radioactivity in plasma by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404

    Time frame: Predose to 168hr

  2. %Ae total radioactivity in plasma by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404

    Time frame: Predose to 168hr

  3. Cum Ae (total) for urine by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404

    Time frame: Predose to 168hr

  4. Cum %Ae (total) for urine by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404

    Time frame: Predose to 168hr

  5. Cum Ae (total) for faeces by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404

    Time frame: Predose to 168hr

  6. Cum %Ae (total) for faeces by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404

    Time frame: Predose to 168hr

  7. Number and structural identification of unknown metabolites of SK-1404 with an AUC of more than 10% of circulating total radioactivity

    Time frame: Predose to 168hr

  8. The peak plasma concentration (Cmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 96hr

  9. The time from dosing at which Cmax was apparent (Tmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 96hr

  10. The elapsed time from dosing at which the analyte was first quantifiable in a concentration vs time profile (Tlag) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 96hr

  11. The area under the concentration-time curve from dosing to the last measurable concentration (AUC(0-last)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 96hr

  12. The area under the concentration-time curve from dosing extrapolated to infinity (AUC(0-inf)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 96hr

  13. The percentage of AUC(0-inf) extrapolated beyond the last measured time point (AUC%extrap) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 96hr

  14. The terminal elimination rate constant calculated from the slope of the apparent elimination phase (lambda-z) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 96hr

  15. The apparent terminal elimination half-life (T1/2) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 96hr

  16. The apparent total clearance (CL/F) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 96hr

  17. The apparent volume of distribution (Vd) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 96hr

  18. The apparent volume of distribution (Vss) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 96hr

  19. The mean residence time (MRT) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 96hr

  20. The peak plasma concentration (Cmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 168hr

  21. The time from dosing at which Cmax was apparent (Tmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 168hr

  22. The elapsed time from dosing at which the analyte was first quantifiable in a concentration vs time profile (Tlag) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 168hr

  23. The area under the concentration-time curve from dosing to the last measurable concentration (AUC(0-last)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 168hr

  24. The area under the concentration-time curve from dosing extrapolated to infinity (AUC(0-inf)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 168hr

  25. The percentage of AUC(0-inf) extrapolated beyond the last measured time point (AUC%extrap) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 168hr

  26. The terminal elimination rate constant calculated from the slope of the apparent elimination phase (lambda-z) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 168hr

  27. The apparent terminal elimination half-life (T1/2) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 168hr

  28. The absolute bioavailability (F, PO vs IV from Part 1) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 168hr

  29. The apparent total clearance (CL/F) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 168hr

  30. The apparent volume of distribution (Vd/F) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 168hr

  31. The mean residence time (MRT) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404

    Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9

    Time frame: Predose to 168hr

  32. To collect further information about the safety and tolerability of IMP

    By assessing physical examination, safety laboratory tests, vital signs, electrocardiograms (ECGs) and AEs.

    Time frame: Predose to 168hr

07

Study locations

1 site
  • Quotient Clinical
    Ruddington, Nottingham NG11 6JS, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02878096
Lead sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
Responsible party
Sponsor
First posted
Aug 25, 2016
Start date
Jul 2016
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Oct 14, 2016

Study contacts

Litza McKenzie, MBChB BScMedSci
principal investigator · Quotient Clinical

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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