NCT02239081

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2014

Typical duration 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

Study Start

First participant enrolled

September 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

4 months

First QC Date

September 9, 2014

Last Update Submit

May 28, 2015

Conditions

Healthy

Keywords

PharmacokineticsSafety

Outcome Measures

Primary Outcomes (2)

  • Number and severity of adverse events

    3 days

  • Pharmacokinetics parameters

    Peak plasma concentration - Cmax by dose Area under the plasma concentration by time - AUC by dose

    96 hours

Study Arms (7)

CTP-730, 5 mg

EXPERIMENTAL

oral suspension, once daily.

Drug: CTP-730Drug: Placebo for CTP-730

CTP-730, 10 mg

EXPERIMENTAL

Oral Suspension, once daily.

Drug: CTP-730Drug: Placebo for CTP-730

CTP-730, 20 mg

EXPERIMENTAL

Oral Suspension, once daily.

Drug: CTP-730Drug: Placebo for CTP-730

CTP-730, 30 mg

EXPERIMENTAL

Oral Suspension, once daily.

Drug: CTP-730Drug: Placebo for CTP-730

CTP-730, 40 mg

EXPERIMENTAL

Oral Suspension, once daily.

Drug: CTP-730Drug: Placebo for CTP-730

CTP-730, 50 mg

EXPERIMENTAL

Oral Suspension, once daily.

Drug: CTP-730Drug: Placebo for CTP-730

CTP-730, 60 mg

EXPERIMENTAL

Oral Suspension, once daily.

Drug: CTP-730Drug: Placebo for CTP-730

Interventions

CTP-730DRUG
CTP-730, 10 mgCTP-730, 20 mgCTP-730, 30 mgCTP-730, 40 mgCTP-730, 5 mgCTP-730, 50 mgCTP-730, 60 mg
Placebo for CTP-730DRUG
CTP-730, 10 mgCTP-730, 20 mgCTP-730, 30 mgCTP-730, 40 mgCTP-730, 5 mgCTP-730, 50 mgCTP-730, 60 mg

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

Location

Study Officials

  • Ginny Braman

    Concert Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 12, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2015

Study Completion

May 1, 2015

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

AU(1)