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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02911870
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 3
• Actual Duration (Months): 7.6
• Patients Per Site Per Month: 11.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: SNAC; Drug: Placebo; Drug: Moxifloxacin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Thorough QTc Trial Evaluating the Effect of SNAC on Cardiac Repolarisation in Healthy Male Subjects
• Actual Study Start Date: Sep 23, 2016
• Actual Primary Completion Date: May 4, 2017
• Actual Study Completion Date: May 11, 2017

Arms and Interventions

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: SNAC; Oral administration; Drug: Placebo; Oral administration; Drug: Moxifloxacin; Oral administration

Outcome Measures

Primary Outcome Measures

1. Number of treatment emergent adverse events [From dosing (day 1) to follow-up (days 8-11)]

   PART A

2. The co-primary endpoints are Fridericia heart rate corrected QT interval (QTcF) [At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8, and 12 hours]

   PART B

Secondary Outcome Measures

1. Maximum observed SNAC plasma concentration [From 0 to 12 hours]

   PART A

2. 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]

   PART B

3. Area under the SNAC plasma concentration time curve [From 0 to 12 hours]

   PART B

4. Maximum observed SNAC plasma concentration [From 0 to 12 hours]

   PART B

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Berlin		Germany	14050

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02911870
• Other Study ID Numbers: NN9924-4247; 2015-002418-54; U1111-1170-7054
• First Posted: Sep 22, 2016
• Last Update Posted: Jan 12, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Moxifloxacin

Study Results

No Results Posted as of Jan 12, 2018