NCT03712241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

October 4, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2019

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

October 1, 2018

Last Update Submit

January 16, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Maximum Plasma Concentration (Cmax)

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

  • 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 Outcomes (1)

  • Number of participants with treatment-related adverse events

    Through study completion approximately 33 to 38 days

Study Arms (4)

Treatment A

EXPERIMENTAL

K-285 dose/application method A

Drug: K-285

Treatment B

EXPERIMENTAL

K-285 dose/application method B

Drug: K-285

Treatment C

EXPERIMENTAL

K-285 dose/application method C

Drug: K-285

Treatment D

ACTIVE COMPARATOR

Indomethacin capsule

Drug: Indomethacin

Interventions

K-285DRUG

Topical

Treatment ATreatment BTreatment C
IndomethacinDRUG

Capsule

Treatment D

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

Indomethacin

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 19, 2018

Study Start

October 4, 2018

Primary Completion

January 6, 2019

Study Completion

January 6, 2019

Last Updated

January 17, 2019

Record last verified: 2019-01

Locations

US(1)