TriangleNCT01469013 · OUTCOME
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of LY3009104
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanomoles*hour (nM*h)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Weeks (Wks) 0, 8, 12, or 20: Predose, 15 to 30 minutes and 1 to 3 hours postdose; Wks 2 or 4 and 15 or 16: Predose; Wks 28, 40, 52, or 64: random single sample.
What was measured
Steady state is achieved when the rate of drug input is equal to the rate of drug elimination. The AUC(tau,ss) at 1 dosing interval is the average concentration of the drug at steady state multiplied by the time of the dosing interval.
Analysis population: All participants who received any study drug and had evaluable data for AUC(tau,ss).
Groups in this outcome
1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
| Group | Source count |
|---|---|
| 1 mg Baricitinib (LY3009104) | 24 |
| 2 mg Baricitinib (LY3009104) | 24 |
| 4 mg Baricitinib (LY3009104) | 48 |
| 8 mg Baricitinib (LY3009104) | 47 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1 mg Baricitinib (LY3009104) | 237 | 28.8 | Not reported | Not reported | Not reported |
| 2 mg Baricitinib (LY3009104) | 525 | 21 | Not reported | Not reported | Not reported |
| 4 mg Baricitinib (LY3009104) | 1020 | 32.5 | Not reported | Not reported | Not reported |
| 8 mg Baricitinib (LY3009104) | 1900 | 24.1 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 28.8
- value
- 237
- group Id
- OG001
- spread
- 21
- value
- 525
- group Id
- OG002
- spread
- 32.5
- value
- 1020
- group Id
- OG003
- spread
- 24.1
- value
- 1900
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 48
- group Id
- OG003
- value
- 47
- units
- Participants
- description
- Steady state is achieved when the rate of drug input is equal to the rate of drug elimination. The AUC(tau,ss) at 1 dosing interval is the average concentration of the drug at steady state multiplied by the time of the dosing interval.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
- id
- OG000
- title
- 1 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
- id
- OG001
- title
- 2 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
- id
- OG002
- title
- 4 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
- id
- OG003
- title
- 8 mg Baricitinib (LY3009104)
- param Type
- GEOMETRIC_MEAN
- population Description
- All participants who received any study drug and had evaluable data for AUC(tau,ss).
- reporting Status
- POSTED
- time Frame
- Weeks (Wks) 0, 8, 12, or 20: Predose, 15 to 30 minutes and 1 to 3 hours postdose; Wks 2 or 4 and 15 or 16: Predose; Wks 28, 40, 52, or 64: random single sample.
- title
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of LY3009104
- type
- SECONDARY
- unit Of Measure
- nanomoles*hour (nM*h)
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Preserved source evidence · Not medical advice