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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: metformin; Drug: RG1662; Other: Omnipaque 300

Study type: Interventional

Funder types: Industry

Identifiers

NCT02342925

WP29394

2014-001851-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

17 participants in 2 patient groups

RG1662 plus metformin

Experimental group

Treatment:

Drug: metformin

Other: Omnipaque 300

Drug: RG1662

metformin alone

Experimental group

Treatment:

Drug: metformin

Other: Omnipaque 300