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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: SNAC; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02911870

NN9924-4247

2015-002418-54 (EudraCT Number)

U1111-1170-7054 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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84 participants in 3 patient groups, including a placebo group

Part A, SNAC

Experimental group

Description:

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

Treatment:

Drug: SNAC

Part A, placebo

Placebo Comparator group

Description:

Single dose at corresponding dose levels.

Treatment:

Drug: Placebo

Part B, SNAC, Placebo, Moxifloxacin

Experimental group

Description:

Subjects will receive 4 different treatments in random order. SNAC dose between 1.2-3.6 mg, Placebo in two different periods, moxifloxacin 400mg.

Treatment:

Drug: Placebo

Drug: SNAC

Drug: Moxifloxacin