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CompletedNCT01690169Updated Feb 28, 2017

Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects

A Phase 1 interventional study of NNC0113-0987 and placebo in Diabetes, Diabetes Mellitus, Type 2 and Healthy, sponsored by Novo Nordisk A/S. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC0113-0987 in healthy male subjects.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Healthy
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 45 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood assessments at the screening visit
  • Body mass index (BMI) above or equal to 18.5 and below 30 kg/m\^ 2

Exclusion criteria

Exclusion Criteria:

  • Male subjects who are sexually active and not surgically sterilised, who or whose partner is unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g., condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 12 weeks following the last dose of trial medication
  • Participation in another trial within 90 days prior to screening
  • Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (including gastroesophageal reflux disease and irritable bowel syndrome), endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorders that might have an impact on the current trial, as judged by the investigator
  • Subjects who are known to have hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for Human Immunodeficiency Virus (HIV) antibodies
  • History of acute idiopathic or chronic pancreatitis
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    NNC0113-0987

    Drug: NNC0113-0987

  • Placebo comparator
    Placebo

    Drug: placebo

Interventions

  • DrugNNC0113-0987

    A single dose for oral administration, up to 7 dose levels will be investigated. If a non-tolerated dose level has been reached, the dose level will not be increased further.

  • Drugplacebo

    A single dose of oral placebo administered.

06

What researchers measure

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: From the dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)

Secondary outcomes

  1. Number and severity of hypoglycaemic episodes

    Time frame: From dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)

  2. AUC, the area under the NNC0113-0987 plasma concentration-time curve

    Time frame: From dosing visit to infinity

  3. Cmax, the maximum plasma concentration of NNC0113-0987

    Time frame: From dosing visit until last PK sampling visit (e.g. day 11)

  4. tmax, the time to maximum plasma concentration of NNC0113-0987

    Time frame: From dosing visit until last PK sampling visit (e.g. day 11)

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Nottingham, NG11 6JS, United Kingdom
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01690169
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Sep 21, 2012
Start date
Sep 14, 2012
Primary completion
Dec 11, 2012
Completion
Dec 11, 2012
Last update
Feb 28, 2017

Study contacts

Global Clinical Registry (GCR,1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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