Clinical trial NCT02911870: A Thorough QTc Trial Evaluating the Effect of SNAC on Cardiac Repolarisation in Healthy Male Subjects.
Official title: A Thorough QTc Trial Evaluating the Effect of SNAC on Cardiac Repolarisation in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-09-22
Enrollment: 84
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Number of treatment emergent adverse events
timeFrame: From dosing (day 1) to follow-up (days 8-11)
measure: The co-primary endpoints are Fridericia heart rate corrected QT interval (QTcF)
timeFrame: At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8, and 12 hours
Secondary outcomes:
measure: Maximum observed SNAC plasma concentration
timeFrame: From 0 to 12 hours
measure: Trial population-specific (accounted for individual subject levels) corrected QT interval (QTcP)
timeFrame: At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8 and 12 hours
measure: Area under the SNAC plasma concentration time curve
timeFrame: From 0 to 12 hours
measure: Maximum observed SNAC plasma concentration
timeFrame: From 0 to 12 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
References:
citation: Granhall C, Baekdal TA, Breitschaft A, Sondergaard FL, Anderson TW, Thomsen M. Absence of QTc Prolongation with Sodium N-(8-[2-Hydroxybenzoyl] Amino) Caprylate (SNAC), an Absorption Enhancer Co-Formulated with the GLP-1 Analogue Semaglutide for Oral Administration. Diabetes Ther. 2021 Sep;12(9):2599-2610. doi: 10.1007/s13300-021-01106-x. Epub 2021 Jul 28.