A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects

• ClinicalTrials.gov Identifier: NCT01087645
• Recruitment Status: Completed
• First Posted: March 16, 2010
• Last Update Posted: February 28, 2017
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Tracking Information

• First Submitted Date: March 12, 2010
• First Posted Date: March 16, 2010
• Last Update Posted Date: February 28, 2017
• Actual Study Start Date: March 12, 2010
• Actual Primary Completion Date: September 16, 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 16, 2010): Number and severity of adverse events (AEs) recorded [ Time Frame: from dosing to Day 22 ]
• Original Primary Outcome Measures (submitted: March 15, 2010): Severity of adverse events [ Time Frame: from dosing to Day 22 ]
• Current Secondary Outcome Measures (submitted: March 15, 2010): The uptake in blood of oral NN9925 [ Time Frame: from 0 to 504 hours ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects
• Official Title: Investigation of Safety, Tolerability and Bioavailability of NN9925 in Healthy Male Subjects
• Brief Summary: This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9925 in healthy male subjects.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Diabetes
• Diabetes Mellitus, Type 2
• Healthy

Intervention

• Drug: NN9925 (oral)
  Subjects will be randomised to receive a single dose of NN9925, at escalating dose levels. Progression to next dose will be based on safety evaluation
• Drug: NN9925 (i.v.)
  As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit
• Drug: placebo
  Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels
• Drug: NN9925 (oral)
  Subjects will be randomised to receive a single dose of NN9925 in up to three different concentrations. The dose will be selected based on the results of part 1
• Drug: placebo
  Subjects will be randomised to receive a single dose of placebo

Study Arms

• Experimental: Trial part 1
  Interventions:

  • Drug: NN9925 (oral)
  • Drug: placebo
• Experimental: Trial part 2
  Interventions:

  • Drug: NN9925 (i.v.)
  • Drug: NN9925 (oral)
  • Drug: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 29, 2010): 70
• Original Estimated Enrollment (submitted: March 15, 2010): 145
• Actual Study Completion Date: September 16, 2010
• Actual Primary Completion Date: September 16, 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male subjects with good general health as judged by the physician
• Body weight of 65-95 kg (both inclusive)
• Body Mass Index (BMI) of 18.5-27.5 kg/m2 (both inclusive)

Exclusion Criteria:

• Known or suspected allergy to trial product or related products
• Acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the physician
• Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states of disease (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the physician

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01087645
• Other Study ID Numbers: NN9925-3779; 2009-016975-31 ( EudraCT Number ); U1111-1113-2537 ( Other Identifier: WHO )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Novo Nordisk A/S
• Study Sponsor: Novo Nordisk A/S
• Collaborators: Not Provided

Investigators

• Study Director: Global Clinical Registry (GCR, 1452); Novo Nordisk A/S

• PRS Account: Novo Nordisk A/S
• Verification Date: February 2017