Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)

NCT ID: NCT01640873

Last Updated: 2018-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-19
• Study Completion Date: 2012-12-20

Brief Summary

This study will assess the initial safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-8655, after single and multiple daily oral administrations to participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MK-8655 80 mg/MK-8655 320 mg

Participants received a single dose of MK-8655, 80 mg on Day 1 and then MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.

Group Type: EXPERIMENTAL

MK-8655

Intervention Type: DRUG

Participants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (q.d.), for 14 consecutive days (Day 3 through Day 16). MK-8655 doses may be adjusted downward based on the results of ongoing studies.

Placebo

Participants received a single dose of placebo to MK-8655, 80 mg on Day 1 and then placebo to MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive Placebo as a single dose on Day 1. Participants will receive Placebo, q.d., for 14 consecutive days (Day 3 through Day 16).

Interventions

MK-8655

Participants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (q.d.), for 14 consecutive days (Day 3 through Day 16). MK-8655 doses may be adjusted downward based on the results of ongoing studies.

Intervention Type: DRUG

Placebo

Participants will receive Placebo as a single dose on Day 1. Participants will receive Placebo, q.d., for 14 consecutive days (Day 3 through Day 16).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female of non-child bearing potential
• Body Mass Index ≤40 kg/m^2
• Diagnosis of Type 2 Diabetes (T2DM) and is either drug naive or is being treated with metformin only
• In good health except for T2DM
• Willing to follow a standard diet
• Nonsmoker and/or no use of nicotine or nicotine-containing products for 6 months

Exclusion Criteria

• Mentally or legally incapacitated
• History of stroke, chronic seizures, or major neurological disorder
• History of clinically significant endocrine (except T2DM), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
• History of neoplastic or myeloproliferative diseases
• Has clinical unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or frequent nausea, bloating or vomiting, severe gastroesophageal reflux or early satiety
• Has a history of Type 1 Diabetes and/or history of ketoacidosis
• Use of any lipid-lowering therapies in the past 3 months
• Non-permitted medication for a co-morbid condition
• Excessive alcohol or caffeine use
• Participation in another investigational study within 4 weeks prior to this study
• A history of significant multiple and/or severe allergies or anaphylactic reactions
• Regular user of any illicit drugs or history of alcohol abuse within 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK-8655-002

Identifier Type: OTHER

Identifier Source: secondary_id

8655-002

Identifier Type: -

Identifier Source: org_study_id