NCT04237597

Brief Summary

A study to compare the pharmacokinetic(s) of K-877 and CSG452 when each drug is administered alone and when both are administered together.

Trial Health

87
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

Timeline
Completed

Started Dec 2019

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

December 17, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

January 16, 2020

Last Update Submit

September 21, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Area under the plasma concentration versus time curve (AUC)

    0 to 24 hours

Study Arms (1)

K-877 & CSG452

EXPERIMENTAL

K-877 Single dose on Day 1 and Day 15 CSG452 Repeat dose on Day 2 Through Day 15

Drug: K-877Drug: CSG452

Interventions

K-877DRUG

K-877 tablets

K-877 & CSG452
CSG452DRUG

CSG452 tablets

K-877 & CSG452

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 volunteer between the ages of 18 and 45 years, inclusive, at Screening.
  • Subject has a BMI of 18 to 30 kg/m2, inclusive, at Screening.

You may not qualify if:

  • Subject has clinically relevant abnormalities at Screening or at Check-in assessments.
  • Subject is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPD Development. LP

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

K-877 compound6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2020

First Posted

January 23, 2020

Study Start

December 17, 2019

Primary Completion

January 31, 2020

Study Completion

March 4, 2020

Last Updated

September 22, 2020

Record last verified: 2020-09

Locations

US(1)