Investigation of Optimal Dosing Conditions for a Long Acting GLP-1 Analogue in Healthy Male Subjects

Sponsor
Novo Nordisk A/S
Study ID
NCT01572753
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 120 mins, no food or liquid is allowed.
  • semaglutide — DRUG
    Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 60 mins, no food or liquid is allowed.
  • semaglutide — DRUG
    Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 30 mins, no food or liquid is allowed.
  • semaglutide — DRUG
    Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 15 mins, no food or liquid is allowed.
  • semaglutide — DRUG
    Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 120 mins, no food or liquid is allowed.
  • semaglutide — DRUG
    Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 60 mins, no food or liquid is allowed.
  • semaglutide — DRUG
    Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 30 mins, no food or liquid is allowed.
  • semaglutide — DRUG
    Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 15 mins, no food or liquid is allowed.

Study Details

This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing conditions for semaglutide (a long acting GLP-1 analogue) in healthy male subjects.

Key Dates

Start date
Apr 12, 2012
Status verified
Feb 2017
Primary completion
Sep 8, 2012
Completion
Sep 8, 2012

Study Design

Enrollment
161 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Post-dose fasting 120 mins/50 ml water
  • Experimental: Post-dose fasting 60 mins/50 ml water
  • Experimental: Post-dose fasting 30 mins/50 ml water
  • Experimental: Post-dose fasting 15 mins/50 ml water
  • Experimental: Post-dose fasting 120 mins/120 ml water
  • Experimental: Post-dose fasting 60 mins/120 ml water
  • Experimental: Post-dose fasting 30 mins/120 ml water
  • Experimental: Post-dose fasting 15 mins/120 ml water

Primary Outcome Measure

AUC 0-24h; Area under the semaglutide concentration curve from time 0-24 hours after the 10th dosing [ Time Frame: 0-24hrs after the 10th dosing ]

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