MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)

NCT00791661 | Completed Phase 1 Results

• 2 other identifiers: 1006-0052008_584
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

A single rising dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM). The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe and well tolerated, based on the assessment of clinical and laboratory evaluations and adverse experiences, in Japanese participants with T2DM.

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced at Least One Adverse Event

  An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.

  from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days)

• Number of Participants Who Discontinued Treatment Due to an Adverse Event

  An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.

  up to approximately 17 days

Secondary Outcomes (6)

• Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006

  Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)

• Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006

  Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)

• Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006

  Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)

• Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006

  Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)

• Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006

  Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)

Study Arms (3)

Panel A: MK-1006 15/30/45

EXPERIMENTAL

Participants received a single rising dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.

Drug: MK-1006; Drug: Placebo

Panel B: MK-1006 60/80/60 fed

EXPERIMENTAL

Participants received a single rising dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.

Drug: MK-1006; Drug: Placebo

Panel C: MK-1006 100/140/170

EXPERIMENTAL

Participants received a single rising dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.

Drug: MK-1006; Drug: Placebo

Interventions

MK-1006 DRUG

MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C.

Panel A: MK-1006 15/30/45; Panel B: MK-1006 60/80/60 fed; Panel C: MK-1006 100/140/170

Placebo DRUG

Matching placebo to MK-1006 in a single oral dose

Panel A: MK-1006 15/30/45; Panel B: MK-1006 60/80/60 fed; Panel C: MK-1006 100/140/170

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Japanese male or female between 20 to 64 years of age
• Diagnosis of type 2 diabetes
• Patient is being treated with diet and exercise alone or single oral anti-hyperglycemic agent

You may not qualify if:

• Subject has a history of type 1 diabetes mellitus
• Subject has a clinical diagnosis of glaucoma
• Subject has donated blood or participated in another clinical study in the past 12 weeks
• Subject is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 14, 2008
• Study Start: November 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 7, 2016
• Results First Posted: October 10, 2012

Record last verified: 2016-01