Japanese Single and Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic (PK) & Pharmacodynamic (PD) Study of AZD7687 (JSMAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01217905
Recruitment Status : Completed
First Posted : October 8, 2010
Last Update Posted : February 13, 2012
Information provided by (Responsible Party):

Brief Summary:
This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound AZD7687. It will also assess how the body handles the drug and how it responds to the drug following single dose followed by multiple dosing over 7 days.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obesity Drug: AZD7687 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD7687 After Administration of Single and Multiple Ascending Doses in Healthy Male Japanese Subjects
Study Start Date : November 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: AZD7687
Oral suspension

Primary Outcome Measures :
  1. Investigate the safety and tolerability of AZD7687 following administration of single and multiple doses [ Time Frame: From screening period to follow-up visit 45 days (Maximum). ]

Secondary Outcome Measures :
  1. Evaluate the pharmacokinetics (PK) (plasma and urine) of AZD7687 and it´s glucuronic acid metabolite (AZ13128940) after single and multiple doses [ Time Frame: Before dose and repeatedly to follow-up visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Suitable veins for cannulation or repeated venipuncture
  • Have a body mass index (BMI) between 19 and 35 kg/m2 and weigh at least 50 kg and no more than 90 kg
  • Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01217905

United Kingdom
Research site
Croydon, United Kingdom
Sponsors and Collaborators
Principal Investigator: Ulrike Lorch, MD MFPM FRCA Richmond Pharmacology Limited

Responsible Party: AstraZeneca Identifier: NCT01217905     History of Changes
Other Study ID Numbers: D2710C00004
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: February 2012

Keywords provided by AstraZeneca:
Phase 1
Type 2 diabetes
Japanese healthy volunteer

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