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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: SNAC; Drug: Placebo; Drug: Moxifloxacin

• Registration Number: NCT02911870
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Study Start: 2016-09-23
• Primary Completion: 2017-05-04
• Study Completion: 2017-05-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 84

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part A, SNAC	SNAC	Single dose of 1.2mg, 2.4mg or 3.6mg increasing for each cohort of trial participants.
Part A, placebo	Placebo	Single dose at corresponding dose levels.
Part B, SNAC, Placebo, Moxifloxacin	SNAC	Subjects will receive 4 different treatments in random order. SNAC dose between 1.2-3.6 mg, Placebo in two different periods, moxifloxacin 400mg.
Part B, SNAC, Placebo, Moxifloxacin	Placebo	Subjects will receive 4 different treatments in random order. SNAC dose between 1.2-3.6 mg, Placebo in two different periods, moxifloxacin 400mg.
Part B, SNAC, Placebo, Moxifloxacin	Moxifloxacin	Subjects will receive 4 different treatments in random order. SNAC dose between 1.2-3.6 mg, Placebo in two different periods, moxifloxacin 400mg.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Berlin, Germany