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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911870
• Other study ID #: NN9924-4247
• Secondary ID: 2015-002418-54U1
• Status: Completed
• Phase: Phase 1
• First received: September 20, 2016
• Last updated: January 11, 2018
• Start date: September 23, 2016
• Est. completion date: May 11, 2017

Study information

• Verified date: January 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 11, 2017
• Est. primary completion date: May 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• SNAC
Oral administration
• Placebo
Oral administration
• Moxifloxacin
Oral administration

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events	PART A	From dosing (day 1) to follow-up (days 8-11)
Primary	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	Maximum observed SNAC plasma concentration	PART A	From 0 to 12 hours
Secondary	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
Secondary	Area under the SNAC plasma concentration time curve	PART B	From 0 to 12 hours
Secondary	Maximum observed SNAC plasma concentration	PART B	From 0 to 12 hours