AZD7687 Multiple Ascending Dose Study

Study Overview
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Brief Summary
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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

Official Title
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A Phase 1, Single Centre, Single-Blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD7687 After Administration of Multiple Ascending Doses in Overweight to Obese But Otherwise Healthy Male Subjects

Conditions
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Overweight, Obese

Intervention / Treatment
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* Drug: AZD7687
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD7687<br>* Oral suspension, once daily. Starting dose of 1mg and with up to 4 dose escalations. Totally 8 doses.<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Oral suspension, once daily. Totally 8 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments) |  | Before, during and after dosing. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Plasma and urine concentrations of AZD7687 and plasma and urine pharmacokinetic parameters |  | 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) |  | Information will be collected from the time of day -2 throughout the study. | 
| Genetic: Blood sampling at one occasion during the study. |  | Once during study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, tolerability, PK, healthy, overweight, obese