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OpenTrials
Completed

NCT Number: NCT00790153

To Evaluate the Hormonal Response to Low Blood Sugar After a Single Oral Dose of AZD1656 Suspension

To evaluate the hormonal response to low blood sugar after a single oral dose of AZD1656 suspension.

Completed

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Chula Vista, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male volunteers.
  • Clinically normal physical findings (incl. Electrocardiogram (ECG)) and laboratory values as judged by the investigator.
  • Have a body mass index (BMI) ≥19 and ≤30

Exclusion criteria

  • Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
  • Intake of any prescribed medicine and OTC drugs (including herbals, vitamins and minerals), except for occasional paracetamol or nasal spray for nasal congestion, within two weeks before the first administration of the investigational product.
  • Daily use of nicotine containing substances.

Treatment and study plan

Insulin

Drug

Insulin infusion given during 3 hours at one occasion.

AZD1656

Drug

Single dose oral suspension given at one occasion.

Primary outcomes

  1. Pharmacodynamic variables

    Time frame: Blood samples taken repeatedly up to 6 hours during study days

Secondary outcomes

  1. Pharmacokinetic variables

    Time frame: Blood samples taken repeatedly during 24 hours on study day sessions

  2. Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)

    Time frame: Taken repeatedly during treatment periods

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Open, Two-Way Cross-Over, Single-Centre, Phase I Study to Assess the Counter Regulatory Response During Hypoglycaemia in Healthy Male Volunteers After a Single Oral Dose of AZD1656 Suspension in Comparison With Insulin Infusion

Important dates

Study start
2008
Study completion
2009
First posted
Nov 13, 2008
Registry last updated
Apr 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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