NCT02276001

Brief Summary

The primary objective of this study is to assess the effects of cyclosporine on the pharmacokinetics of K-877 in healthy adult subjects.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

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

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
Last Updated

October 27, 2014

Status Verified

October 1, 2014

Enrollment Period

1 month

First QC Date

October 23, 2014

Last Update Submit

October 24, 2014

Conditions

Healthy

Keywords

Adult Volunteers

Outcome Measures

Primary Outcomes (1)

  • Maximum concentration (Cmax)

    72 hours

Secondary Outcomes (1)

  • Area under concentration curve (AUC)

    72 hours

Study Arms (2)

K-877

EXPERIMENTAL

K-877

Drug: K-877

K-877 with Cyclosporine

EXPERIMENTAL

K-877 with Cyclosporine

Drug: K-877Drug: Cyclosporine

Interventions

K-877DRUG
K-877K-877 with Cyclosporine
CyclosporineDRUG
K-877 with Cyclosporine

Eligibility Criteria

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

You may qualify if:

  • Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
  • Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
  • Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.

You may not qualify if:

  • Subject has clinically relevant abnormalities in the screening or check in assessments.
  • Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
  • Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPD

Austin, Texas, 75744, United States

Location

MeSH Terms

Interventions

K-877 compoundCyclosporine

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Stuart Campbell

    Kowa Research Institute, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2014

First Posted

October 27, 2014

Study Start

June 1, 2014

Primary Completion

July 1, 2014

Last Updated

October 27, 2014

Record last verified: 2014-10

Locations

US(1)