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

Healthy Clinical Trial

Official title:

A Phase I, Open-label, Randomized, 4-period Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of K-285 Compared With a Single Oral Dose of Indomethacin Capsule in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712241
• Other study ID #: K-285-101
• Status: Completed
• Phase: Phase 1
• Start date: October 4, 2018
• Est. completion date: January 6, 2019

Study information

• Verified date: January 2019
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 6, 2019
• Est. primary completion date: January 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• K-285
Topical
• Indomethacin
Capsule

Locations

Country	Name	City	State
United States	PPD Development, LP	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax)		Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4
Primary	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	Number of participants with treatment-related adverse events		Through study completion approximately 33 to 38 days