A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Obstetric Labour, Premature; Premature Ejaculation

Treatments: Drug: GSK557296

Study type: Interventional

Funder types: Industry

Identifiers

NCT00549211

OTB109039

Details and patient eligibility

About

A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.

Enrollment: 42 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males who are 18 to 45 years of age
• Body mass index between 19 and 30 with a body weight greater than 110 pounds and deemed healthy by a physician
• Non-smokers

Exclusion criteria

• Alcohol consumption averaging more than 7 drinks per week
• Positive for Hepatitis C antibody, Hepatitis B antigen or HIV
• Any use of prescription drugs or non prescription drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind