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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03712241
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: K-285 Drug: Indomethacin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : October 4, 2018
Actual Primary Completion Date : January 6, 2019
Actual Study Completion Date : January 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment A
K-285 dose/application method A
Drug: K-285
Topical

Experimental: Treatment B
K-285 dose/application method B
Drug: K-285
Topical

Experimental: Treatment C
K-285 dose/application method C
Drug: K-285
Topical

Active Comparator: Treatment D
Indomethacin capsule
Drug: Indomethacin
Capsule




Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: Through study completion approximately 33 to 38 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712241


Locations
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United States, Texas
PPD Development, LP
Austin, Texas, United States, 78744
Sponsors and Collaborators
Kowa Research Institute, Inc.

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Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT03712241     History of Changes
Other Study ID Numbers: K-285-101
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action