Clinical Trial Search

Primary: Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a…

Primary: Number of Participants With Solicited Adverse Events (SEs) After Dose 1 — 12; 5; 8; 6 participants

Primary: Cmax (the Maximum Observed Plasma Concentration) — 1153.9; 1625.3 ng/mL

Primary: Time to Reach the Peak Plasma Concentration (Tmax) — 4.4; 4.1; 4.1 hours — p=0.809

Primary: Maximum Observed Serum Concentration (Cmax) — 0.702; 0.998; 0.413; 0.759 ng/mL

Primary: Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) — 1.1751; 1.13253; 1.1046; 1.17129 ratio…

Primary: Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose) — 6; 1…

Primary: Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) — 7062.76; 7187.14…

Primary: Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy — 5; 5; 5; 5 mg BID

Primary: Maximum Observed Plasma Concentration (Cmax) — 30.43; 26.96; 38.85 ng/mL

Primary: Participants Experiencing Dose Limiting Toxicity (DLT) — 0; 2 participants

Primary: Maximum Tolerated Dose (MTD) — NA; NA; NA; NA mg/kg

Primary: Single Dose: Maximum Observed Plasma Concentration (Cmax) — 20.732; 32.007; 53.123 ng/mL

Primary: Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs) — 3 participants

Primary: Number of Participants With Adverse Events — 12; 5; 7; 0 participants