NCT01185353 · OUTCOME

Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104

A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy · Source last updated 2017-06-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: GEOMETRIC_MEAN
Unit: nanomoles/Liter (nmol/L)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Baseline through 24 weeks

Analysis population: All randomized participants who received at least 1 dose of LY3009104 with evaluable LY3009104 PK data.

Groups in this outcome

1 mg LY3009104

1 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.

2 mg LY3009104

2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B. MTX was administered orally as background therapy.

4 mg LY3009104

4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B. MTX was administered orally as background therapy.

8 mg LY3009104

8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
1 mg LY3009104	47
2 mg LY3009104	91
4 mg LY3009104	91
8 mg LY3009104	50

Reported measurements

Source class 1

Values in nanomoles/Liter (nmol/L) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
1 mg LY3009104	36.5	36.1	Not reported	Not reported	Not reported
2 mg LY3009104	59.1	21.3	Not reported	Not reported	Not reported
4 mg LY3009104	119.0	20.5	Not reported	Not reported	Not reported
8 mg LY3009104	241.0	22.9	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
36.1
value
36.5
group Id
OG001
spread
21.3
value
59.1
group Id
OG002
spread
20.5
value
119.0
group Id
OG003
spread
22.9
value
241.0

denoms

counts
group Id
OG000
value
47
group Id
OG001
value
91
group Id
OG002
value
91
group Id
OG003
value
50
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
1 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
id
OG000
title
1 mg LY3009104
description
2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B. MTX was administered orally as background therapy.
id
OG001
title
2 mg LY3009104
description
4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B. MTX was administered orally as background therapy.
id
OG002
title
4 mg LY3009104
description
8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
id
OG003
title
8 mg LY3009104

param Type

GEOMETRIC_MEAN

population Description

All randomized participants who received at least 1 dose of LY3009104 with evaluable LY3009104 PK data.

reporting Status

POSTED

time Frame

Baseline through 24 weeks

title

Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104

type

SECONDARY

unit Of Measure

nanomoles/Liter (nmol/L)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice