A Study of the Effect of RG1662 on Metformin in Healthy Volunteers

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This single-center, non-randomized, open-label, two treatment, two period, fixed sequence crossover study will investigate the effect of RG1662 treatment on the activity of key renal transporters in healthy male and female participants using metformin. The effect of RG1662 on other renal function parameters will also be explored.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Healthy male or female participants, aged 18 to 60 years, inclusive

• A body mass index between 18 to 32 kg/m2, inclusive

• Informed consent and agreement to comply with study restrictions

Exclusion Criteria:

• A history of epilepsy, convulsions or significant head injury

• Significant history of drug allergy or a known hypersensitivity to any of the ingredients of any of the study treatments

• Pregnant or lactating

• Impaired renal function or clinically relevant hematuria

• A history of lactic acidosis, or risk factors for lactic acidosis

• Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions