Evaluate the Safety, Tolerability, & Pharmacokinetics of K-285 Compared With Indomethacin Capsule in Healthy Adults

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: K-285; Drug: Indomethacin

• Registration Number: NCT03712241
• Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary

This study is to compare the PK parameters of multiple doses and applications of K-285 with a single dose of indomethacin capsule.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-01
• Study Start: 2018-10-04
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-19
• Status Verified: 2019-01
• Primary Completion: 2019-01-06
• Study Completion: 2019-01-06
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Subject provides written informed consent before any study specific evaluation is performed.
• Subject is a healthy adult male or female aged 18 to 45 years, inclusive.
• Subject has a BMI of 18 to 30 kg/m2, inclusive.
• Subject meets all inclusion criteria outlined in the clinical study protocol.

Exclusion Criteria

• Subject has abnormal findings or assessments that are clinically noteworthy at Screening or Admission (Day -1).
• Subject has a supine blood pressure after resting for 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 50 mm Hg diastolic at Screening or Admission (Day -1).
• Subject has a supine heart rate after resting for 5 minutes that is outside the range of 40 to 100 beats per minute at Screening or Admission (Day -1).
• Subject does not meet any exclusion criteria outlined in the clinical study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	K-285	K-285 dose/application method A
Treatment B	K-285	K-285 dose/application method B
Treatment C	K-285	K-285 dose/application method C
Treatment D	Indomethacin	Indomethacin capsule

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax)	Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4
Area under the plasma versus concentration time curve (AUC)	Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	Through study completion approximately 33 to 38 days

Trial Locations

Locations (1)

PPD Development, LP; 🇺🇸 Austin, Texas, United States