A Study to Investigate in Healthy Volunteers (Part 1) and in Patients With Type 2 Diabetes Mellitus (Part 2) the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of RO6799477

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02164266

Enrollment

Registered

2014-06-16

Start date

2014-06-30

Completion date

2014-12-31

Last updated

2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer, Type 2 Diabetes

Brief summary

This study is designed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO6799477 following once daily oral administration for 2 weeks in healthy volunteers (Part 1) and in Type 2 diabetes patients (T2D) (Part 2). The anticipated time on study treatment is two weeks.

Interventions

DRUGPlacebo

Matching placebo daily oral administration

DRUGRO6799477

Daily oral administration of RO6799477

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Part 1 Inclusion criteria: * Right-handed male volunteers * Aged 18-45 years, inclusive * Healthy participants, as determined by screening assessments and Principal Investigator's judgment * Healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis * Body Mass Index (BMI) of 18-30 kg/m2 inclusive, with body weight in the range of 50-100 kg Part 2 Inclusion Criteria: * Patients with type 2 diabetes according to WHO criteria diagnosed for at least 3 months prior to screening * Male or female patients, 40 to 65 years of age, inclusive * Type 2 diabetic patients who are either drug naive (diet & exercise alone) or on a stable dose of metformin for at least 3 months prior to screening or willing to safely stop sulfonylurea medications at least 2 weeks prior to first dose administration and until follow-up visit * BMI of 23-42 kg/m2, inclusive

Exclusion criteria

Part 1

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events (AEs)	Up to 9 weeks

Secondary

Measure	Time frame
Pharmacokinetic parameters derived from plasma and urine concentrations of RO6799477, area under the concentration time curve (AUC), Cmax	Day 1 and Day 14
Fasting serum glucose	Up to 9 weeks
Fasting serum insulin (Part 2 only)	Up to 9 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026