A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects

NCT01037582 | Completed Phase 1

• 3 other identifiers: NN9924-36912009-012366-31U1111-1112-7564
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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 NN9924 in healthy male subjects.

Conditions

Diabetes; Diabetes Mellitus, Type 2; Healthy

Outcome Measures

Primary Outcomes (1)

• Number and severity of adverse events (AEs) recorded

  from dosing to Day 22

Secondary Outcomes (1)

• The uptake in blood of oral NN9924 compared to i.v. and s.c. administration of the same compound

  from 0 to 504 hours

Study Arms (2)

Trial part 1

EXPERIMENTAL

Drug: NN9924 (oral); Drug: placebo

Trial part 2

EXPERIMENTAL

Drug: NN9924 (oral); Drug: placebo; Drug: NN9924 (s.c.); Drug: NN9924 (i.v.)

Interventions

NN9924 (oral) DRUG

Subjects will be randomized to receive a single dose of NN9924, at escalating dose levels. Progression to next dose will be based on safety evaluation.

Trial part 1

placebo DRUG

Subjects will receive a single dose of placebo as a comparator to NN9924, at all dose levels.

Trial part 1

NN9924 (s.c.) DRUG

As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit

Trial part 2

NN9924 (i.v.) DRUG

As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit.

Trial part 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects with good general health as judged by the Investigator
• Body weight of 65.0-95.0 kg (both inclusive)
• Body Mass Index (BMI) of 18.5-27.5 kg/m\^2 (both inclusive)

You may not qualify if:

• 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 Investigator
• Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states (celiac disease, lactose intolerance or chronic pancreatitits), as judged by the Investigator

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Harrow, HA1 3UJ, United Kingdom

Location

Related Publications (1)

• Granhall C, Donsmark M, Blicher TM, Golor G, Sondergaard FL, Thomsen M, Baekdal TA. Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2019 Jun;58(6):781-791. doi: 10.1007/s40262-018-0728-4.

  PMID: 30565096 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2009
• First Posted: December 23, 2009
• Study Start: December 17, 2009
• Primary Completion: May 7, 2010
• Study Completion: May 7, 2010
• Last Updated: January 3, 2019

Record last verified: 2019-01

Locations

GB (1)