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

NCT ID: NCT02342925

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-05-31

Brief Summary

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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

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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RG1662 plus metformin

Group Type EXPERIMENTAL

Omnipaque 300

Intervention Type OTHER

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

RG1662

Intervention Type DRUG

Oral administration twice daily

metformin

Intervention Type DRUG

Single 850 mg dose of metformin

metformin alone

Group Type EXPERIMENTAL

Omnipaque 300

Intervention Type OTHER

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

metformin

Intervention Type DRUG

Single 850 mg dose of metformin

Interventions

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Omnipaque 300

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

Intervention Type OTHER

RG1662

Oral administration twice daily

Intervention Type DRUG

metformin

Single 850 mg dose of metformin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2014-001851-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WP29394

Identifier Type: -

Identifier Source: org_study_id