TABLE 1.

Studies providing source data for the population PK analyses^a

Study	Study design and population	Treatment course	Publication	ClinicalTrials.gov registration no.
1	Phase 1, single ascending dose, multiple dose, absolute bioavailability, and venous tolerability in healthy subjects	Single ascending doses of 100, 200, 300, and 400 mg tedizolid phosphateb i.v.; multiple doses of 200 mg tedizolid phosphate i.v. for 7 days (absolute bioavailability, 200 mg tedizolid phosphate i.v. and orally; venous tolerability, 200 mg tedizolid phosphate i.v. for 3 days)	5	NCT00983255
2	Phase 1, single oral dose in healthy young (18- to 45-yr-old) and healthy elderly (≥65-yr-old) subjects	Oral 200-mg tedizolid phosphate dose	21	NCT01496677
3	Phase 1, a single dose or two doses in patients with advanced renal disease (dialyzed and nondialyzed) and healthy controls	One or two i.v. 200-mg tedizolid phosphate doses	18	NCT01452828
4	Phase 1, single oral dose in subjects with moderate or severe hepatic impairment and healthy controls	One oral 200-mg tedizolid phosphate dose	18	NCT01431833
5	Phase 2, randomized, double-blind, noncontrolled, multicenter study of adults (≥18 to 75 yr old) with cSSSI	Once-daily 200-, 300-, or 400-mg oral tedizolid disodium phosphateb dose (as capsules) for 5 to 7 days	3	NCT00761215
6	Phase 3, randomized, double-blind, double-dummy, multicenter study of adults ≥18 yr old with ABSSSI caused by suspected or documented Gram-positive pathogens	Multiple oral doses of tedizolid phosphate tablets at 200 mg once daily for 6 days vs oral linezolid at 600 mg every 12 h for 10 days	1	NCT01170221
7	Same as for study 6, except that adolescents ≥12 yr old were included	Multiple doses of i.v. to oral tedizolid phosphate at 200 mg once daily for 6 days vs i.v. to oral linezolid at 600 mg every 12 h for 10 days	2	NCT01421511

^aABSSSI, acute bacterial skin and skin structure infections; cSSSI, complicated skin and skin structure infections; i.v., intravenous; PK, pharmacokinetics.

^bTedizolid disodium phosphate was an alternative prodrug used in early clinical development.