AZD7687 Multiple Ascending Dose Study

Phase 1CompletedNCT01119352

AstraZeneca45 enrolled

Overview

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD7687 following multiple ascending dose administrations in in overweight to obese but otherwise healthy male subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Overweight Obese

Interventions

AZD7687DRUG

Oral suspension, once daily. Starting dose of 1mg and with up to 4 dose escalations. Totally 8 doses.

PlaceboDRUG

Oral suspension, once daily. Totally 8 doses

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * suitable veins for cannulation or repeated venepuncture. * Have a body mass index (BMI) between 27 and 35 kg/m2 Exclusion Criteria: * Fasting serum (S)-glucose ≥7.0 mmol/L or non-fasting S-glucose ≥11.1 mmol/L at screening. * Any eating disorder or actively attempting to loose weight within 3 months prior to enrolment. * Smoking more than 7 cigarettes per week from time of consent

Locations (1)

Research Site

London, United Kingdom

Outcomes

Primary Outcomes

Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)

Time frame: Before, during and after dosing.

Secondary Outcomes

Pharmacokinetics: Plasma and urine concentrations of AZD7687 and plasma and urine pharmacokinetic parameters

Time frame: Information will be collected from the time of day -2 throughout the study.

Pharmacodynamic Biomarker sampling: (Triacylglycerol in serum, triacylglycerol, diacylglycerol, insulin and free fatty acids in plasma. Triacylglycerol and diacylglycerol in adipose tissue)

Time frame: Information will be collected from the time of day -2 throughout the study.

Genetic: Blood sampling at one occasion during the study.

Time frame: Once during study

Data from ClinicalTrials.gov

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