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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02164266
First received: June 6, 2014
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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) (P art 2). The anticipated time on study treatment is two weeks.


Condition Intervention Phase
Healthy Volunteer, Type 2 Diabetes
Drug: Placebo
Drug: RO6799477
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Incidence of adverse events (AEs) [ Time Frame: Up to 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters derived from plasma and urine concentrations of RO6799477, area under the concentration time curve (AUC), Cmax [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
  • Fasting serum glucose [ Time Frame: Up to 9 weeks ] [ Designated as safety issue: No ]
  • Fasting serum insulin (Part 2 only) [ Time Frame: Up to 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: July 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: Healthy Volunteers Drug: Placebo
Matching placebo daily oral administration
Drug: RO6799477
Daily oral administration of RO6799477
Experimental: Part 2: Patients with T2D, Group A
Low dose daily oral administration of RO6799477
Drug: Placebo
Matching placebo daily oral administration
Drug: RO6799477
Daily oral administration of RO6799477
Experimental: Part 2: Patients with T2D, Group B
High dose daily oral administration of RO6799477
Drug: Placebo
Matching placebo daily oral administration
Drug: RO6799477
Daily oral administration of RO6799477

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Exclusion criteria:

  • Any clinically relevant history or the presence of e.g. respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, etc. disease or diseases
  • Disorders of central nervous system, psychiatric disorders, behavioral disturbances (e.g. cerebrovascular events, depression, post-traumatic stress disorder [PTSD], anxiety, bipolar disorder, severe migraine, Parkinson's disease)
  • Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times per year
  • Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study

Part 2 Exclusion Criteria:

  • Type 1 diabetes
  • Acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes
  • Evidence or history of clinically significant diabetic complications such as clinically severe diabetic peripheral neuropathy, clinically significant nephropathy as judged by the investigator, or pre-proliferative/proliferative diabetic retinopathy as judged by the investigator or already diagnosed by the diabetologist or general practitioner
  • Disorders of central nervous system, psychiatric disorders, behavioral disturbances
  • Clinically significant history or presence of bronchopulmonary, gastrointestinal, hematological, lymphatic, neurological, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, infectious, connective tissue or inflammatory diseases, and any type of cancer (with the exception of treated basal cell carcinoma of the skin) or other clinically significant disease
  • Use of anti-diabetic drugs other than metformin or sulfonylureas within 2 months prior to screening
  • Any condition or disease detected during the medical interview / physical examination that would render the patient unsuitable for the study, place the patient at undue risk or interfere with the ability of the patient to complete the study in the opinion of the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02164266

Contacts
Contact: Reference Study ID Number: BP29205 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Netherlands
Recruiting
Leiden, Netherlands, 2333
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02164266     History of Changes
Other Study ID Numbers: BP29205, 2014-000718-78
Study First Received: June 6, 2014
Last Updated: August 26, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects [Centrale Commissie Mensgebonden Onderzoek (CCMO)]

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014