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

NCT02342925 | Completed Phase 1

• 2 other identifiers: WP293942014-001851-21
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

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

  Up to 9 weeks

• Incidence of adverse events (AEs)

  Up to 9 weeks

Study Arms (2)

RG1662 plus metformin

EXPERIMENTAL

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

metformin alone

EXPERIMENTAL

Other: Omnipaque 300; Drug: metformin

Interventions

Omnipaque 300 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 plus metformin; metformin alone

RG1662 DRUG

Oral administration twice daily

RG1662 plus metformin

metformin DRUG

Single 850 mg dose of metformin

RG1662 plus metformin; metformin alone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

Iohexol; Metformin

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Biguanides; Guanidines; Amidines

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 21, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

GB (1)