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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Other: Omnipaque 300; Drug: RG1662; Drug: metformin

• Registration Number: NCT02342925
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-21
• Study Start: 2015-02
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RG1662 plus metformin	Omnipaque 300	-
metformin alone	Omnipaque 300	-
RG1662 plus metformin	RG1662	-
RG1662 plus metformin	metformin	-
metformin alone	metformin	-

Primary Outcome Measures

Name	Time	Method
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]	Up to 9 weeks

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics: renal function measured by derivation of glomerular filtration rate (GFR) from plasma concentrations of iohexol.	Up to 9 weeks
Pharmacokinetic parameters derived from plasma concentrations of RG1662: AUC, Cmax, time to maximum concentration (Tmax), and minimum concentration (Ctrough)[composite outcome measure]	Up to 9 weeks
Incidence of adverse events (AEs)	Up to 9 weeks