Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments azp-531, placebo
Phase phase 1
Sponsor Alizé Pharma
Start date July 2013
End date October 2015
Trial size 108 participants
Trial identifier NCT02040012, AZP01-CLI-001

Summary

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
subcut administration once or twice daily
azp-531
(Placebo Comparator)
subcut administration once or twice daily
placebo

Primary Outcomes

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

Secondary Outcomes

Measure
To determine the plasma pharmacokinetic (PK) profile of AZP-531 after single and multiple doses
time frame: 1 to 14 days

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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.

Additional Information

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
Principal investigator James Ritter, MD Professor
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Alizé Pharma.