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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT03712241

Run by

Kowa Research Institute, Inc.

People needed

15

Starts

2018-10-04

Expected to finish

2019-01-06

Last updated by the study team

2019-01-17

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PPD Development, LP — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.