Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers

A Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of CTP-692 in Fed and Fasted Conditions in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03830463

Enrollment

Registered

2019-02-05

Start date

2019-01-24

Completion date

2019-03-28

Last updated

2019-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses of CTP-692 in healthy volunteers.

Interventions

DRUGCTP-692

Single oral dose

DRUGPlacebo

Single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events as a Measure of Safety	48 hours
Measurement of CTP-692 exposure in plasma under fasted conditions	48 hours
Measurement of CTP-692 exposure in plasma under fed conditions	48 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026