A Thorough QTc Trial Evaluating the Effect of SNAC on Cardiac Repolarisation in Healthy Male Subjects.

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to evaluate the effect of SNAC on cardiac repolarisation in healthy male subjects

Official Title
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A Thorough QTc Trial Evaluating the Effect of SNAC on Cardiac Repolarisation in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: SNAC
* Drug: Placebo
* Drug: Moxifloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male aged 18-55 years (both inclusive) at the time of signing informed consent Body mass index (BMI) between 18.5-28.0 kg/m^2 (both inclusive) Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs and clinical laboratory tests performed during the screening visit, as judged by the investigator Normal electrocardiogram (ECG) at screening or minor findings considered not clinically significant, as judged by the investigator Exclusion Criteria: Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per week), or subject smoking equal to or less than 5 cigarettes or the equivalent per week who is not able or willing to refrain from smoking and use of nicotine substitute products within 48 hours prior to each dosing and during the in-patient periods Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening Sitting blood pressure at screening (after resting for at least 5 minutes) outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,gastric bypass surgery)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A, SNAC<br>Single dose of 1.2mg, 2.4mg or 3.6mg increasing for each cohort of trial participants. | Drug: SNAC<br>* Oral administration<br>|
| Placebo Comparator: Part A, placebo<br>Single dose at corresponding dose levels. | Drug: Placebo<br>* Oral administration<br>|
| Experimental: Part B, SNAC, Placebo, Moxifloxacin<br>Subjects will receive 4 different treatments in random order. SNAC dose between 1.2-3.6 mg, Placebo in two different periods, moxifloxacin 400mg. | Drug: SNAC<br>* Oral administration<br>Drug: Placebo<br>* Oral administration<br>Drug: Moxifloxacin<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse events | PART A | From dosing (day 1) to follow-up (days 8-11) | 
| The co-primary endpoints are Fridericia heart rate corrected QT interval (QTcF) | PART B | At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8, and 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed SNAC plasma concentration | PART A | From 0 to 12 hours | 
| Trial population-specific (accounted for individual subject levels) corrected QT interval (QTcP) | PART B | At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8 and 12 hours | 
| Area under the SNAC plasma concentration time curve | PART B | From 0 to 12 hours | 
| Maximum observed SNAC plasma concentration | PART B | From 0 to 12 hours |