ID

40947

Description

The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitus Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

Keywords

Versions (2)
  1. 4/23/20 4/23/20 -
  2. 6/7/20 6/7/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 7, 2020

DOI

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License

Creative Commons BY-NC 4.0
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A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin

English

Concomitant Medications - Repeating Form, Logs/Repeats 4-RF-DF

1 forms  
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0013227
Drug Name (Trade Name preferred)
Description

Drug Name (Trade Name preferred)

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Modified reported term
Description

Item is not required

Data type

text

Alias
UMLS CUI [1]
C2826819
Unit Dose
Description

This item is conditional

Data type

float

Alias
UMLS CUI [1]
C2826646
Units
Description

Units

Data type

integer

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency
Description

Frequency

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439603
Route
Description

Route

Data type

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1]
C2826696
Start Date and Time
Description

Start Time is optional

Data type

partialDatetime

Alias
UMLS CUI [1]
C2826825
Taken prior to study
Description

Taken prior to study

Data type

integer

Alias
UMLS CUI [1]
C2826667
Ongoing?
Description

Ongoing?

Data type

integer

Alias
UMLS CUI [1]
C2826666
Stopped End Date and Time
Description

End time is optional

Data type

partialDatetime

Alias
UMLS CUI [1]
C2826744
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C1522314
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Similar models

Concomitant Medications - Repeating Form, Logs/Repeats 4-RF-DF

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Drug Name (Trade Name preferred)
Item
Drug Name (Trade Name preferred)
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Unit Dose
Item
Unit Dose
float
C2826646 (UMLS CUI [1])
Item
Units
integer
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Units
Code List
Units
CL Item
Actuation (1)
CL Item
Ampoule (2)
CL Item
Application (3)
CL Item
Area under curve (4)
CL Item
Bottle (5)
CL Item
Capsule (6)
CL Item
Cubic centimeter (7)
CL Item
Cup (8)
CL Item
Gamma per kilogram per minute (9)
CL Item
Gram (10)
CL Item
Drops (11)
CL Item
100 International units/ml (12)
CL Item
Inhalation (13)
CL Item
International units (14)
CL Item
International units per kilogram (15)
CL Item
International units per kilogram per hour (16)
CL Item
International units per millilitre (17)
CL Item
Litre (18)
CL Item
Lozenge (19)
CL Item
Litre per minute (20)
CL Item
Minimum alveolar concentration (21)
CL Item
Mega becquerels (MBq) (22)
CL Item
Microgram (MCG) (23)
CL Item
Micrograms per hour (24)
CL Item
Microgram/kilogram (25)
CL Item
Microgram/kilogram per minute (26)
CL Item
Micrograms per minute (27)
CL Item
Micrograms per millilitre (28)
CL Item
Microlitre (29)
CL Item
Milliequivalent (30)
CL Item
Milliequivalent per 24 hours (31)
CL Item
Milligram (32)
CL Item
Milligram per day (33)
CL Item
Milligram per hour (34)
CL Item
Milligram/kilogram (35)
CL Item
Milligram/kilogram per hour (36)
CL Item
Milligram/kilogram per minute (37)
CL Item
Milligram/metre squared (38)
CL Item
Milligram/millilitre (39)
CL Item
Milligrams percent (40)
CL Item
Million international units (41)
CL Item
Millilitre (42)
CL Item
Millilitre per hour (43)
CL Item
Millilitre per minute (44)
CL Item
Millimole (45)
CL Item
Megaunits (million units) (46)
CL Item
Nebule (47)
CL Item
Ounce (48)
CL Item
Patch (49)
CL Item
Percent (50)
CL Item
Puff (51)
CL Item
Sachet (52)
CL Item
Spray (53)
CL Item
Suppository (54)
CL Item
Tablet (55)
CL Item
Tablespoon (56)
CL Item
Teaspoon (57)
CL Item
Microgram (UG) (58)
CL Item
Units per hour (59)
CL Item
Units per kilogram per minute (60)
CL Item
Units per minute (61)
CL Item
Units (62)
CL Item
Unknown (63)
CL Item
Vial (64)
Item
Frequency
integer
C2347852 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per day (4)
CL Item
5 times per week (5)
CL Item
AC (6)
CL Item
BID (7)
CL Item
Continuous infusion (8)
CL Item
Every 2 weeks (9)
CL Item
Every 3 weeks (10)
CL Item
Every 3 months (11)
CL Item
Every other day (12)
CL Item
At bedtime (13)
CL Item
Once a month (14)
CL Item
Once a week (15)
CL Item
Once daily (16)
CL Item
Once only (17)
CL Item
PC (18)
CL Item
PRN (19)
CL Item
Q2H (20)
CL Item
Q3D (21)
CL Item
Q4D (22)
CL Item
Q4H (23)
CL Item
Q6H (24)
CL Item
Q8H (25)
CL Item
Q12H (26)
CL Item
QAM (27)
CL Item
QH (28)
CL Item
QID (29)
CL Item
QPM (30)
CL Item
TID (31)
CL Item
Unknown (32)
Item
Route
integer
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Epidural (1)
CL Item
Gastrostomy tube (2)
CL Item
Intra-arterial (3)
CL Item
Intra-articular (4)
CL Item
Intra-bursa (5)
CL Item
Intradermal (6)
CL Item
Inhalation (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Injection (11)
CL Item
Intraocular (12)
CL Item
Intraosteal (13)
CL Item
Intraperitoneal (14)
CL Item
Intrathecal (15)
CL Item
Intrauterine (16)
CL Item
Intravenous (17)
CL Item
Nasogastric (18)
CL Item
Nasal (19)
CL Item
Right eye (20)
CL Item
Ophtalmic (21)
CL Item
Left eye (22)
CL Item
Otic (23)
CL Item
Other (24)
CL Item
Both eyes (25)
CL Item
Oral (26)
CL Item
Rectal (27)
CL Item
Subcutaneous (28)
CL Item
Sublingual (29)
CL Item
Transdermal (30)
CL Item
Topical (31)
CL Item
Unknown (32)
CL Item
Vaginal (33)
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Start Date and Time
Item
Start Date and Time
partialDatetime
C2826825 (UMLS CUI [1])
Item
Taken prior to study
integer
C2826667 (UMLS CUI [1])
Taken prior to study
Code List
Taken prior to study
CL Item
Yes (1)
CL Item
No (2)
Item
Ongoing?
integer
C2826666 (UMLS CUI [1])
Ongoing?
Code List
Ongoing?
CL Item
Yes (1)
CL Item
No, specify End Date and Time in the next question (2)
Stopped End Date and Time
Item
Stopped End Date and Time
partialDatetime
C2826744 (UMLS CUI [1])
C2347852 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
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