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

January 17, 2014
January 17, 2014
July 2013
November 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
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 ]
Same as current
 
A Study to Evaluate AZP531 in Healthy, Overweight/Obese Patients With Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overweight, Obesity, Type 2 Diabetes Mellitus
Drug: AZP-531
Experimental: AZP-531
AZP-531
Intervention: Drug: AZP-531
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
108
November 2014
November 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact: James Ritter, MD Professor + 44(0)207 910 7713 james.ritter@quintiles.com
United Kingdom
 
NCT02040012
AZP01-CLI-001
No
Alizé Pharma
Alizé Pharma
Not Provided
Principal Investigator: James Ritter, MD Professor Quintiles Drug Research Unit at Guy's Hospital
Alizé Pharma
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP