A Relative Bioavailability Study Measuring the Extent and Rate of Absorption of Different Tablet Formulations of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01221519
First received: October 12, 2010
Last updated: January 18, 2012
Last verified: January 2012
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Purpose
The purpose of this study is to assess the relative bioavailability by measuring the extent and rate of absorption of different tablet formulations of AZD1656 in T2DM patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus High Blood Sugar |
Drug: AZD1656 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Randomized, Open, 4-way Crossover, Single Center, Phase I Relative Bioavailability Study in Type 2 Diabetes Mellitus Patients to Measure the Extent and Rate of Absorption of AZD1656 From Different Tablet Formulations |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656. [ Time Frame: Blood samples will be collected from predose to 48 hrs at each treatment period 1 ] [ Designated as safety issue: No ]
- Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656. [ Time Frame: Blood samples will be collected from predose to 48 hrs at each treatment period 1 ] [ Designated as safety issue: No ]
- Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656. [ Time Frame: Blood samples will be collected from predose to 48 hrs at each treatment period 1 ] [ Designated as safety issue: No ]
- Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656. [ Time Frame: Blood samples will be collected from predose to 48 hrs at each treatment period 2 ] [ Designated as safety issue: No ]
- Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656. [ Time Frame: Blood samples will be collected from predose to 48 hrs at each treatment period 2 ] [ Designated as safety issue: No ]
- Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656. [ Time Frame: Blood samples will be collected from predose to 48 hrs at each treatment period 2 ] [ Designated as safety issue: No ]
- Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656. [ Time Frame: Blood samples will be collected from predose to 48 hrs at each treatment period 3 ] [ Designated as safety issue: No ]
- Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656. [ Time Frame: Blood samples will be collected from predose to 48 hrs at each treatment period 3 ] [ Designated as safety issue: No ]
- Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656. [ Time Frame: Blood samples will be collected from predose to 48 hrs at each treatment period 3 ] [ Designated as safety issue: No ]
- Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656. [ Time Frame: Blood samples will be collected from predose to 48 hrs at each treatment period 4 ] [ Designated as safety issue: No ]
- Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656. [ Time Frame: Blood samples will be collected from predose to 48 hrs at each treatment period 4 ] [ Designated as safety issue: No ]
- Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656. [ Time Frame: Blood samples will be collected from predose to 48 hrs at each treatment period 4 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the safety of AZD1656 by assessing a panel of adverse events measures: physical examination, electrocardiogram, pulse and blood pressure, weight and laboratory, variables including plasma glucose. [ Time Frame: start of treatment until follow up ] [ Designated as safety issue: Yes ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 1 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t). [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 1 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 1 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 1 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 1 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 2 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t). [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 2 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 2 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 2 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 2 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 3 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t). [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 3 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 3 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 3 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 3 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 4 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t). [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 4 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 4 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 4 ] [ Designated as safety issue: No ]
- Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½. [ Time Frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 4 ] [ Designated as safety issue: No ]
- pharmacodynamics of AZD1656 following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-4) and AUC(0-24) for glucose [ Time Frame: PK blood samples will be collected from predose to 48 hrs after treatment period and P-glucose on Day 1 of each treatment period ] [ Designated as safety issue: No ]
- pharmacodynamics of AZD1656 following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-4) for insulin [ Time Frame: PK blood samples will be collected from predose to 48 hrs after treatment period and P-glucose on Day 1 of each treatment period ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | September 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
AZD1656
|
Drug: AZD1656
3 different formulations, A, B and C of AZD1656 assessed before food intake and formulation B also after food intake
|
|
Experimental: 2
AZD1656
|
Drug: AZD1656
3 different formulations, A, B and C of AZD1656 assessed before food intake and formulation B also after food intake
|
|
Experimental: 3
AZD1656
|
Drug: AZD1656
3 different formulations, A, B and C of AZD1656 assessed before food intake and formulation B also after food intake
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Males or females of non-childbearing potential (post-menopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation) aged ≥18 years. Females will be defined as post-menopausal if last menstruation period was >1 year ago and serum follicle stimulating hormone (FSH) is within the post-menopausal range, or if age >50 years and with last menstruation period >2 years ago.
- A confirmed clinical diagnosis of T2DM for at least 1 year, treated with metformin as a single treatment or in combination with one other oral anti-diabetic (ie, DPPIV inhibitor or SU) for at least 2 months prior to screening. Doses of anti-diabetic treatment should have been stable for at least 1 month prior to screening.
- Treatment with at least 1000mg of Metformin for 2 months and being stable on the Metformin Therapy for 1 month
- Hb A1c >6.5% (international standard) at enrolment.
- Body mass index (BMI) between ≥19 and ≤42 kg/m2.
Exclusion Criteria:
- Clinically significant illness or clinically relevant trauma, as judged by the Investigator, within 2 weeks prior to the first administration of AZD1656
- Participation in another clinical study during the 30 days prior to screening or intake of another investigational drug within 30 days (or at least 5 x t1/2 of the drug) prior to the first administration of AZD1656.
- History of, or ongoing, ischemic heart disease or heart failure. Stroke, transitory ischemic attack, or symptomatic peripheral arterial disease within the last 6 months.
- Clinically significant abnormalities in ECG, clinical chemistry, hematology or urinalysis results.
- Positive test for Hepatitis B surface antigen (HBsAg) or antibodies to human immunodeficiency virus (HIV) or Hepatitis C virus.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221519
Locations
| United States, Minnesota | |
| Research Site | |
| St. Paul, Minnesota, United States | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Eva Johnsson, MD, PhD | AstraZeneca Sweden |
| Principal Investigator: | Mark Matson, MD | Prism Research |
| Study Chair: | Mirjana Kujacic Kujacic, MD, PhD | AstraZeneca R&D Mölndal |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01221519 History of Changes |
| Other Study ID Numbers: | D1020C00033 |
| Study First Received: | October 12, 2010 |
| Last Updated: | January 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Phase I Bioavailability Type 2 Diabetes Mellitus |
Diabetic treatment Metformin High blood sugar |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Hyperglycemia |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013