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

NCT02911870 | Completed Phase 1

• 3 other identifiers: NN9924-42472015-002418-54U1111-1170-7054
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Maximum observed SNAC plasma concentration

  From 0 to 12 hours

• 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

• Area under the SNAC plasma concentration time curve

  From 0 to 12 hours

• Maximum observed SNAC plasma concentration

  From 0 to 12 hours

Study Arms (3)

Part A, SNAC

EXPERIMENTAL

Single dose of 1.2mg, 2.4mg or 3.6mg increasing for each cohort of trial participants.

Drug: SNAC

Part A, placebo

PLACEBO COMPARATOR

Single dose at corresponding dose levels.

Drug: Placebo

Part B, SNAC, Placebo, Moxifloxacin

EXPERIMENTAL

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; Drug: Placebo; Drug: Moxifloxacin

Interventions

SNAC DRUG

Oral administration

Part A, SNAC; Part B, SNAC, Placebo, Moxifloxacin

Placebo DRUG

Oral administration

Part A, placebo; Part B, SNAC, Placebo, Moxifloxacin

Moxifloxacin DRUG

Oral administration

Part B, SNAC, Placebo, Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Location

Related Publications (1)

• 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.

  PMID: 34319564 DERIVED

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 22, 2016
• Study Start: September 23, 2016
• Primary Completion: May 4, 2017
• Study Completion: May 11, 2017
• Last Updated: January 12, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)