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OpenTrials
Completed

NCT Number: NCT03712241

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

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development, LP

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

K-285

Drug

Topical

Indomethacin

Drug

Capsule

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4

  2. Area under the plasma versus concentration time curve (AUC)

    Time frame: Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4

Secondary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: Through study completion approximately 33 to 38 days

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2018
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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