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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT01037582 (opens ClinicalTrials.gov in a new tab)Other idNN9924-3691Other id2009-012366-31Other idU1111-1112-7564Other id2009
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
155 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

United Kingdom

Start
17 Dec 2009
Primary completion
7 May 2010
Completion
7 May 2010
First posted
23 Dec 2009 (estimated)
Last update posted
3 Jan 2019
Conditions
Diabetes · Diabetes Mellitus, Type 2 · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011
  1. Ph 1

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

    NCT01037582

    17 Dec 2009 to 7 May 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • NN9924 (oral)Drug
  • placeboDrug
  • NN9924 (oral)Drug
  • placeboDrug
  • NN9924 (s.c.)Drug
  • NN9924 (i.v.)Drug

Arms2

  • Experimental

    Trial part 1

  • Experimental

    Trial part 2

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number and severity of adverse events (AEs) recorded

    Time frame · from dosing to Day 22

Secondary outcomes(1)

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

    Time frame · from 0 to 504 hours

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2019

6 results

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.

Granhall et al. 2019Clinical pharmacokineticscited by 130

PMID 30565096DOI 10.1007/s40262-018-0728-4PUB-30565096

Free to read · publisher termsCC BY-NC6 results
Read at sourceSee results (6)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 50 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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) 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 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

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