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CompletedNCT03880253Updated Jun 13, 2019

Multiple Ascending Dose Study of CTP-692 in Healthy Volunteers

A Phase 1 interventional study of CTP-692 in Healthy, sponsored by Concert Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-13.

Sponsored by Concert Pharmaceuticals (part of Sun Pharmaceutical Industries Limited) · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was May 2019, 7 years 5 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Concert Pharmaceuticals is the lead sponsor of 33 studies on the registry; none are open to participants now.

Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.

First submitted before Concert Pharmaceuticals became part of Sun Pharmaceutical Industries Limited.

Browse Concert Pharmaceuticals studies →All Sun Pharmaceutical Industries Limited studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    CTP-692 Low Dose or Matching Placebo

    Once daily dosing

    Drug: CTP-692

  • Experimental
    CTP-692 Mid Dose or Matching Placebo

    Once daily dosing

    Drug: CTP-692

  • Experimental
    CTP-692 High Dose or Matching Placebo

    Once daily dosing

    Drug: CTP-692

Interventions

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events as a measure of safety

    Time frame: Assessments done Day 1 - 9

  2. Measurement of CTP-692 exposure in plasma

    Time frame: Assessments done Day 1 - 9

07

Study locations

1 site
  • Collaborative Neuroscience Network, LLC
    Long Beach, California 90806, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03880253
Lead sponsor
Concert Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 19, 2019
Start date
Apr 10, 2019
Primary completion
May 16, 2019
Completion
May 16, 2019
Last update
Jun 13, 2019

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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