Table 1.
Study | Population | N | Study Design Pharmacokinetic Sampling/Subject | Active Treatment | Dose(s)a | Reference |
---|---|---|---|---|---|---|
1 | Healthy subjects | 56 | Single‐dose, randomized, placebo‐controlled | Upadacitinib | 1, 3, 6, 12, 24, 36, 48 mg | Mohamed et al20 |
2, Part 1 | Healthy subjects | 44 | Multiple‐dose, randomized, placebo‐controlled | Upadacitinib | 3, 6, 12, 24 mg BID | Mohamed et al20 |
2, Part 2 | Subjects with mild to moderate RA | 14 | Multiple dose, randomized, placebo‐controlled | Upadacitinib | 6, 12, 24 mg BID | Mohamed et al20 |
2, Part 3 | Healthy subjects | 9 | Multiple dose, open‐label | Tofacitinib | 5 mg BID | – |
BID, twice daily; RA, rheumatoid arthritis.
aUpadacitinib and tofacitinib were administered in the study as immediate‐release formulations.