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

NCT ID: NCT02911870

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-23
• Study Completion Date: 2017-05-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A, SNAC

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

Group Type: EXPERIMENTAL

SNAC

Intervention Type: DRUG

Oral administration

Part A, placebo

Single dose at corresponding dose levels.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral administration

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.

Group Type: EXPERIMENTAL

SNAC

Intervention Type: DRUG

Oral administration

Placebo

Intervention Type: DRUG

Oral administration

Moxifloxacin

Intervention Type: DRUG

Oral administration

Interventions

SNAC

Oral administration

Intervention Type: DRUG

Placebo

Oral administration

Intervention Type: DRUG

Moxifloxacin

Oral administration

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novo Nordisk Investigational Site

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 34319564 (View on PubMed)

Other Identifiers

2015-002418-54

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1170-7054

Identifier Type: OTHER

Identifier Source: secondary_id

NN9924-4247

Identifier Type: -

Identifier Source: org_study_id