ID

34288

Description

Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01690169

Link

https://clinicaltrials.gov/show/NCT01690169

Keywords

  1. 1/16/19 1/16/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 16, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Diabetes NCT01690169

Eligibility Diabetes NCT01690169

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01690169
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ecg), vital signs, and blood assessments at the screening visit
Description

ID.1

Data type

boolean

body mass index (bmi) above or equal to 18.5 and below 30 kg/m^ 2
Description

ID.2

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
male subjects who are sexually active and not surgically sterilised, who or whose partner is unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g., condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 12 weeks following the last dose of trial medication
Description

ID.3

Data type

boolean

participation in another trial within 90 days prior to screening
Description

ID.4

Data type

boolean

subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (including gastroesophageal reflux disease and irritable bowel syndrome), endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorders that might have an impact on the current trial, as judged by the investigator
Description

ID.5

Data type

boolean

subjects who are known to have hepatitis or who are carriers of the hepatitis b surface antigen (hbsag) or hepatitis c antibodies, or have a positive result to the test for human immunodeficiency virus (hiv) antibodies
Description

ID.6

Data type

boolean

history of acute idiopathic or chronic pancreatitis
Description

ID.7

Data type

boolean

Similar models

Eligibility Diabetes NCT01690169

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01690169
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ecg), vital signs, and blood assessments at the screening visit
boolean
ID.2
Item
body mass index (bmi) above or equal to 18.5 and below 30 kg/m^ 2
boolean
Item Group
C0680251 (UMLS CUI)
ID.3
Item
male subjects who are sexually active and not surgically sterilised, who or whose partner is unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g., condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 12 weeks following the last dose of trial medication
boolean
ID.4
Item
participation in another trial within 90 days prior to screening
boolean
ID.5
Item
subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (including gastroesophageal reflux disease and irritable bowel syndrome), endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorders that might have an impact on the current trial, as judged by the investigator
boolean
ID.6
Item
subjects who are known to have hepatitis or who are carriers of the hepatitis b surface antigen (hbsag) or hepatitis c antibodies, or have a positive result to the test for human immunodeficiency virus (hiv) antibodies
boolean
ID.7
Item
history of acute idiopathic or chronic pancreatitis
boolean

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