NCT02040012

Brief 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P75+ for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2013

Longer than P75 for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

June 18, 2015

Status Verified

June 1, 2015

Enrollment Period

2.3 years

First QC Date

January 17, 2014

Last Update Submit

June 17, 2015

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 to 14 days

Secondary Outcomes (1)

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

    1 to 14 days

Other Outcomes (1)

  • To obtain exploratory data on the effects of AZP-531 on the pharmacodynamic (PD) markers

    1 to 14 days

Study Arms (2)

AZP-531

ACTIVE COMPARATOR

subcut administration once or twice daily

Drug: AZP-531

Mannitol

PLACEBO COMPARATOR

subcut administration once or twice daily

Drug: Placebo

Interventions

AZP-531DRUG
AZP-531
PlaceboDRUG
Mannitol

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quintiles Drug Research Unit at Guy's Hospital

London, London, SE1 1YR, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

cyclic des-acyl ghrelin (6-13)

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • James Ritter, MD Professor

    Quintiles Drug Research Unit at Guy's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 20, 2014

Study Start

July 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

June 18, 2015

Record last verified: 2015-06

Locations

GB(1)