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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: SNAC; Drug: Moxifloxacin

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part A, SNAC; Single dose of 1.2mg, 2.4mg or 3.6mg increasing for each cohort of trial participants.	Drug: SNAC; Oral administration
PLACEBO_COMPARATOR: Part A, placebo; Single dose at corresponding dose levels.	Drug: Placebo; Oral administration
EXPERIMENTAL: Part B, SNAC, Placebo, 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.	Drug: Placebo; Oral administration; Drug: SNAC; Oral administration; Drug: Moxifloxacin; Oral administration

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 23, 2016
• Primary Completion (ACTUAL): May 4, 2017
• Study Completion (ACTUAL): May 11, 2017

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (ESTIMATE): September 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: NN9924-4247; 2015-002418-54 (EUDRACT_NUMBER); U1111-1170-7054 (OTHER: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No