A Safety and Tolerability Study of CTP-730 in Healthy Volunteers

A Randomized, Double-blind, Single Ascending Dose, Safety, Tolerability, Pharmacokinetics Study of CTP-730 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02239081

Enrollment

Registered

2014-09-12

Start date

2014-09-30

Completion date

2015-05-31

Last updated

2015-05-29

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

Conditions

Healthy

Keywords

Pharmacokinetics, Safety

Brief summary

This is a Phase 1, single center, single-ascending dose, randomized study

Detailed description

Following a Screening period of up to 21 days, eight (8) subjects in each cohort, 6 subjects randomized to CTP-730 and 2 subjects randomized to placebo, will be admitted to the clinical research unit (CRU) on the evening before dosing and remain sequestered at the study site until after the last inpatient blood sample is collected at 48 hours.

Interventions

DRUGCTP-730

DRUGPlacebo for CTP-730

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.

Exclusion criteria

* Current significant medical condition, laboratory abnormality, or psychiatric illness * 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 * Elevated liver function tests greater than twice the upper limit of normal * Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody * 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
Number and severity of adverse events	3 days	—
Pharmacokinetics parameters	96 hours	Peak plasma concentration - Cmax by dose Area under the plasma concentration by time - AUC by dose

Countries

Australia

Outcome results

None listed

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