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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Overweight
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014