Multiple Ascending Doses Study of CG400549

CrystalGenomics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: placebo 960 mg; Drug: CG400549 640 mg; Drug: Placebo 320mg; Drug: CG400549 640mg; Drug: CG400549 320 mg; Drug: CG400549 960 mg; Drug: Placebo 640mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01848470

CG400549-1-02

Details and patient eligibility

About

The purpose of this study is to investigate the safety and tolerability of 3 multiple and escalating dose regimens of CG400549 administered orally in healthy volunteers.

Full description

This is a Phase 1, 3 cohorts study consisting of a randomised, double-blind, and placebo-controlled design.

Enrollment: 32 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age:18-55 years, inclusive
• Body Mass Index :19-30 kg/m2, inclusive
• Sex:male
• Other criteria:healthy; non-smoking or smoking ≤ 10 cigarettes/day

Exclusion criteria

• Evidence of clinically relevant pathology
• History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month of study
• Presence or history of esophageal or gastroduodenal ulceration within 1 month before screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 8 patient groups, including a placebo group

E1. CG400549 640mg

Experimental group

Description:

CG400549 640mg BID on Day 1-5 and QD on Day 6 in the fed-state

Treatment:

Drug: CG400549 640mg

E2: CG400549 320mg

Experimental group

Description:

CG400549 320mg QD on Day 1-5 in the fed-state.

Treatment:

Drug: CG400549 320 mg

E3: CG400549 640mg

Experimental group

Description:

CG400549 640mg QD on Day 1-5 in the fed-state.

Treatment:

Drug: CG400549 640 mg

E4: CG400549 960mg

Experimental group

Description:

CG400549 960mg QD on Day 1-5 in the fed-state.

Treatment:

Drug: CG400549 960 mg

P1 Placebo

Placebo Comparator group

Description:

Placebo 640mg BID on Day 1-5 and QD on Day 6 in the fed-state

Treatment:

Drug: Placebo 640mg

Drug: Placebo 640mg

P2: Placebo 320mg

Placebo Comparator group

Description:

Placebo 320mg QD on Day 1-5 in the fed-state

Treatment:

Drug: Placebo 320mg

P3 Placebo 640mg

Placebo Comparator group

Description:

Placebo 640mg QD on Day 1-5 in the fed-state.

Treatment:

Drug: placebo 960 mg

P4: Placebo 960mg

Placebo Comparator group

Description:

Placebo 960mg QD on Day 1-5 in the fed-state.

Treatment:

Drug: Placebo 640mg

Drug: Placebo 640mg