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

Kowa

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: K-285; Drug: Indomethacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03712241

K-285-101

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

Treatment A

Experimental group

Description:

K-285 dose/application method A

Treatment:

Drug: K-285

Treatment B

Experimental group

Description:

K-285 dose/application method B

Treatment:

Drug: K-285

Treatment C

Experimental group

Description:

K-285 dose/application method C

Treatment:

Drug: K-285

Treatment D

Active Comparator group

Description:

Indomethacin capsule

Treatment:

Drug: Indomethacin