Multiple Ascending Dose Study in Healthy Volunteers

A Phase I Single Center, Double-Blind, Placebo-Controlled, Multiple Dose-Ascending Study to Evaluate the Pharmacokinetics and Tolerability of CTP-730 Immediate Release at Steady State in Healthy Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02404922

Enrollment

Registered

2015-04-01

Start date

2015-03-31

Completion date

2015-06-30

Last updated

2016-02-05

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

Conditions

Healthy

Keywords

Safety/Efficacy Study, Randomized, Double Blind

Brief summary

This study will assess in healthy male and female subjects the safety, tolerability and pharmacokinetics (PK) profiles of Immediate Release CTP-730 at steady state following 7 days of dosing. Three doses of Immediate Release (IR) CTP-730 capsules will be studied.

Interventions

DRUGCTP-730

DRUGPlacebo for CTP-730

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy adult males and females between 18 and 50 years of age. * Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2

Exclusion criteria

* Medical, psychiatric illness or history of depression that could, in the investigator's opinion, compromise the subject's safety * Significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. * History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions. * PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcB / QTcF interval \> 450 msec obtained at screening visit or prior to the first dose of study drug. * Liver function tests greater than the upper limit of normal. * Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening. * Urinalysis positive for protein or glucose. * A positive screen for alcohol, drugs of abuse, or tobacco use. * Inability to comply with food and beverage restrictions during study participation. * Donation or blood collection or acute loss of blood prior to screening.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic Profile	96 hours	The primary pharmacokinetics parameters of interest will be time to attainment of steady state, and Cmax, Tmax, AUC0-24hr, AUClast and AUCinf at steady state
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	24 hours	Adverse events categorized by body system and MedDRA term

Countries

Australia

Outcome results

None listed

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