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

Hoffmann-La Roche17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy Volunteer

Interventions

Omnipaque 300OTHER

647 mg/mL of iohexol, equivalent to 300 mg/mL of iodine, used for assessment of glomerular function and other measure of renal function

RG1662DRUG

Oral administration twice daily

metforminDRUG

Single 850 mg dose of metformin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Leeds, United Kingdom

Outcomes

Primary Outcomes

Pharmacokinetic parameters of metformin derived from plasma and urine concentrations of metformin: area under the concentration-time curve (AUC), maximum concentration (Cmax), renal clearance (CLr) [composite outcome measure]

Time frame: Up to 9 weeks

Secondary Outcomes

Pharmacokinetic parameters derived from plasma concentrations of RG1662: AUC, Cmax, time to maximum concentration (Tmax), and minimum concentration (Ctrough)[composite outcome measure]

Time frame: Up to 9 weeks

Pharmacodynamics: renal function measured by derivation of glomerular filtration rate (GFR) from plasma concentrations of iohexol.

Time frame: Up to 9 weeks

Incidence of adverse events (AEs)

Time frame: Up to 9 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.