A Study to Evaluate AZP531 in Healthy, Overweight/Obese Patients With Type 2 Diabetes Mellitus

This study is currently recruiting participants.
Verified January 2014 by Alizé Pharma
Sponsor:
Information provided by (Responsible Party):
Alizé Pharma
ClinicalTrials.gov Identifier:
NCT02040012
First received: January 17, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

Objectives:

Primary Objectives

  • To investigate the safety and tolerability of single ascending doses of AZP- 531 in healthy volunteers.
  • To investigate the safety and tolerability of single and multiple ascending doses of AZP-531 in overweight/obese volunteers.
  • To investigate the safety and tolerability of single and multiple ascending doses of AZP-531 in patients with type 2 diabetes mellitus.

Secondary Objectives • To determine the plasma pharmacokinetic (PK) profile of AZP-531 after single and multiple doses.

Exploratory Objectives

• To obtain exploratory data on the effects of AZP-531 on the pharmacodynamic (PD) markers of blood glucose, interstitial glucose, insulin, and plasma acylated ghrelin (AG) and unacylated ghrelin (UAG) in Parts A, B and C; glucagon, lipid profiles including free fatty acids (FFA), glycerol and pancreatic polypeptide in Parts B and C; and fructosamine in Part C only.


Condition Intervention Phase
Overweight, Obesity, Type 2 Diabetes Mellitus
Drug: AZP-531
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZP-531 in Healthy Volunteers, Overweight/Obese Volunteers and Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Alizé Pharma:

Primary Outcome Measures:
  • To investigate the number of adverse events of single and multiple ascending doses AZP-531 in healthy volunteers, in overweight/obese volunteers, in patients with type 2 diabetes mellitus. [ Time Frame: 1 to 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the plasma pharmacokinetic (PK) profile of AZP-531 after single and multiple doses [ Time Frame: 1 to 14 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • To obtain exploratory data on the effects of AZP-531 on the pharmacodynamic (PD) markers [ Time Frame: 1 to 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: July 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZP-531
AZP-531
Drug: AZP-531

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Part A: Healthy male volunteers, aged 18 to 50 years (inclusive) with a body mass index (BMI) of 20 to 28 kg/m2 (inclusive).
  • Part B: Female (of non-childbearing potential) and male overweight/obese volunteers, aged 18 to 65 years (inclusive) with a BMI of 28 to 38 kg/m2 (inclusive).
  • Part C: Female (of non-childbearing potential) and male patients with a confirmed diagnosis of type 2 diabetes mellitus for at least 3 months

Exclusion Criteria:

  • Part A: Females and male volunteers who smoke and/or use other nicotine products within 6 months of screening are excluded.
  • Part B: Current or ex-smokers with a smoking history of greater than 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year) and any clinically significant abnormalities in physical examination, electrocardiogram (ECG), clinical chemistry, haematology, coagulation or urinalysis results at screening or on admission, as judged by the Investigator.
  • Part C: Current or ex-smokers with a smoking history of greater than 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year), any clinically significant abnormalities other than those attributed to type 2 diabetes mellitus in physical examination, ECG, clinical chemistry, haematology, coagulation or urinalysis results at screening or on admission, as judged by the Investigator, and estimated glomerular filtration rate <40 mL*min-1*1.73m-2 calculated by the Modification of Diet in Renal Disease formula.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02040012

Contacts
Contact: James Ritter, MD Professor + 44(0)207 910 7713 james.ritter@quintiles.com

Locations
United Kingdom
Quintiles Drug Research Unit at Guy's Hospital Recruiting
London, United Kingdom, SE1 1YR
Contact: James Ritter, Professor         
Principal Investigator: James Ritter, Professor         
Sponsors and Collaborators
Alizé Pharma
Investigators
Principal Investigator: James Ritter, MD Professor Quintiles Drug Research Unit at Guy's Hospital
  More Information

No publications provided

Responsible Party: Alizé Pharma
ClinicalTrials.gov Identifier: NCT02040012     History of Changes
Other Study ID Numbers: AZP01-CLI-001
Study First Received: January 17, 2014
Last Updated: January 17, 2014
Health Authority: NRESCommittee, London,UK ':'

Keywords provided by Alizé Pharma:
Overweight, Obese,Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014