Phase 1 N=33 Drug Interaction Study
Antivirals/HIV
Primary: Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB) — 1565; 2311 nanograms*hour /milliliters (ng*h/mL)
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=34 Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
Stomach Neoplasms
Primary: Number of Participants With First-cycle Dose Limiting Toxicities (DLTs) — 1; 0 Participants
Phase 1 N=28 Effects of Etravirine on Endothelial Function in HIV-uninfected Adults: A Pilot Study
Endothelial Function · Lipids · Insulin Resistance
Primary: Flow-mediated Dilation (FMD) of the Brachial Artery — 0.03 Percentage — p=0.36
Phase 1 N=75 Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients
Pain · Fever
Primary: Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen — 40.1; 20.1; 16.7; 19.3 micrograms per…
Phase 1 N=14 Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
Infant Respiratory Distress Syndrome · Respiratory Insufficiency · Apnea of Prematurity
Primary: pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values — 50; 45 mm Hg — p=0.011
Phase 1 N=36 Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions
Healthy
Primary: Cmax for Norethindrone(Maximum Observed Concentration of Drug Substance in Plasma) — 10.08; 9.90 ng/mL
Phase 1 N=16 Study of Dasatinib (BMS-354825) in Patients With Solid Tumors
Tumors
Primary: Maximum Tolerated Dose (MTD) and Maximum Acceptable Dose (MAD) of Dasatinib as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to…
Phase 1 N=12 A Safety Study Of Sunitinib In Combination With Pemetrexed In Patients With Advanced Solid Malignancies
Neoplasm, Malignant
Primary: Number of Participants With Adverse Events — 6; 6; 0; 0 Participants
Phase 1 N=22 Anastrozole 1 mg Tablets Under Fed Conditions
Healthy
Primary: Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma) — 14.1; 14.2 ng/mL
Phase 1 N=22 Anastrozole 1 mg Tablets Under Fasting Conditions
Healthy
Primary: Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma) — 17.1; 17.8 ng/mL
Phase 1 N=105 Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
Cataract Extraction
Primary: The Aqueous Humor Drug Concentration. — 0.1349; 0.6681; 0.1251 µg/mL
Phase 1 N=124 V710 First-In-Man (FIM) Study (V710-001)
Staphylococcal Infections
Primary: Number of Vaccine-related Serious Adverse Experiences Following Vaccination — 0; 0; 0; 0 Participants
Phase 1 N=12 Pharmacokinetic and Pharmacodynamic Interactions Between the Cholesterol-lowering Ezetimibe and the Non-nucleoside Reverse Transcriptase Inhibitor Efavirenz During Chronic Treatment in Healthy Volunteers With Reference to Intestinal Expression of CYP3A4, UGT1A1, ABCB1 and ABCC2
Pharmacokinetics · Drug Interactions · Pharmacodynamics
Primary: AUC0-24h of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15 — 51.9 ng*h/ml
Phase 1 N=158 Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)
Carcinoma
Primary: Maximum Tolerated Dose (MTD) of Sorafenib in Combination With Paclitaxel and Carboplatin — 400 mg
Phase 1 N=33 Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Non-Fasting Conditions
Healthy
Primary: Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma) — 52.77; 53.65 ng/mL