NCT03880253

Brief Summary

This study will assess in healthy male and female subjects the safety and pharmacokinetic (PK) profiles of 3 dose levels of CTP-692 following 7 days of dosing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2019

Shorter than P25 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

First Submitted

Initial submission to the registry

March 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

April 10, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2019

Completed
Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

1 month

First QC Date

March 15, 2019

Last Update Submit

June 12, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Number of participants with adverse events as a measure of safety

    Assessments done Day 1 - 9

  • Measurement of CTP-692 exposure in plasma

    Assessments done Day 1 - 9

Study Arms (3)

CTP-692 Low Dose or Matching Placebo

EXPERIMENTAL

Once daily dosing

Drug: CTP-692

CTP-692 Mid Dose or Matching Placebo

EXPERIMENTAL

Once daily dosing

Drug: CTP-692

CTP-692 High Dose or Matching Placebo

EXPERIMENTAL

Once daily dosing

Drug: CTP-692

Interventions

CTP-692DRUG

Placebo or CTP-692

CTP-692 High Dose or Matching PlaceboCTP-692 Low Dose or Matching PlaceboCTP-692 Mid Dose or Matching Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult males and females between 18 and 55 years of age, inclusive
  • Body weight ≥ 55 kg and body mass index within the range of 18 to 32 kg/m2, inclusive

You may not qualify if:

  • Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug
  • Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody
  • History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions
  • Positive drug or alcohol test at screening or prior to the first dose of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Collaborative Neuroscience Network, LLC

Long Beach, California, 90806, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 19, 2019

Study Start

April 10, 2019

Primary Completion

May 16, 2019

Study Completion

May 16, 2019

Last Updated

June 13, 2019

Record last verified: 2019-06

Locations

US(1)