A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
NCT ID: NCT01597713
Last Updated: 2015-05-29
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
83 participants
INTERVENTIONAL
2012-05-31
2012-10-31
Brief Summary
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The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362, placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC 0148-0000-0362 administered orally or intravenously.
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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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Part 1, level 1-7 escalating doses
NNC 0148-0000-0362
Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group
insulin glargine
As an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group
placebo
Subjects will receive a single dose of oral placebo within each dose group
Part 2, cross-over
NNC 0148-0000-0362
Single low dose administered orally in randomised order on three dosing visits separated by a wash-out period
NNC 0148-0000-0362
Single high dose administered i.v. in randomised order on three dosing visits separated by a wash-out period
NNC 0148-0000-0362
Single high dose administered orally in randomised order on three dosing visits separated by a wash-out period
Interventions
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NNC 0148-0000-0362
Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group
insulin glargine
As an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group
placebo
Subjects will receive a single dose of oral placebo within each dose group
NNC 0148-0000-0362
Single low dose administered orally in randomised order on three dosing visits separated by a wash-out period
NNC 0148-0000-0362
Single high dose administered i.v. in randomised order on three dosing visits separated by a wash-out period
NNC 0148-0000-0362
Single high dose administered orally in randomised order on three dosing visits separated by a wash-out period
Eligibility Criteria
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Inclusion Criteria
* Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion Criteria
* Previous participation in this trial. Participation is defined as randomised
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator
* Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
18 Years
55 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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Neuss, , Germany
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2011-005147-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1125-2969
Identifier Type: OTHER
Identifier Source: secondary_id
NN1954-3936
Identifier Type: -
Identifier Source: org_study_id
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