A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects
NCT ID: NCT01037582
Last Updated: 2019-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
155 participants
INTERVENTIONAL
2009-12-17
2010-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Trial part 1
NN9924 (oral)
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.
placebo
Subjects will receive a single dose of placebo as a comparator to NN9924, at all dose levels.
Trial part 2
NN9924 (oral)
Subjects will be randomized to receive a single dose of NN9924 in one of three different concentrations. The dose will be selected based on the results of part 1.
placebo
Subjects will be randomized to receive a single dose of placebo.
NN9924 (s.c.)
As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit
NN9924 (i.v.)
As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit.
Interventions
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NN9924 (oral)
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.
placebo
Subjects will receive a single dose of placebo as a comparator to NN9924, at all dose levels.
NN9924 (oral)
Subjects will be randomized to receive a single dose of NN9924 in one of three different concentrations. The dose will be selected based on the results of part 1.
placebo
Subjects will be randomized to receive a single dose of placebo.
NN9924 (s.c.)
As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit
NN9924 (i.v.)
As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
MALE
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Harrow, , United Kingdom
Countries
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References
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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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2009-012366-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1112-7564
Identifier Type: OTHER
Identifier Source: secondary_id
NN9924-3691
Identifier Type: -
Identifier Source: org_study_id
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