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

NCT02040012 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2015-06-18

No results posted yet for this study

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)

Conditions

Interventions

DRUG

AZP-531

DRUG

Placebo

Sponsors & Collaborators

  • Alizé Pharma

    lead INDUSTRY

Principal Investigators

  • James Ritter, MD Professor · Quintiles Drug Research Unit at Guy's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02040012 on ClinicalTrials.gov