Phase 1 N=46 A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors
Advanced Solid Tumors
Primary: Maximum Tolerated Dose (MTD): Part 1 — 10.0 milligram/kilogram (mg/kg)
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=13 Metazym for the Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD)
Metachromatic Leukodystrophy (MLD)
Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 4; 5; 4 participants
Phase 1 N=2 Open Label Single Dose Phase I Trial of BI 201335 to Study Pharmacokinetics and Safety in Patients With Compensated Liver Cirrhosis
Hepatitis C · Liver Cirrhosis
Primary: AUC 0-∞ — 7240; 24700 h*ng/mL
Phase 1 N=13 Nonconvulsive Electrotherapy: a Proof-of-concept Trial
Depressive Disorder · Bipolar Disorder · Schizoaffective Disorder
Primary: Change in Score on the 17-item Hamilton Depression Rating Scale — -11.6 units on a scale — p=0.001
Phase 1 N=29 A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
Malignant Melanoma, Neoplasms
Primary: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Digoxin — 14.9; 27.7 hour*ng/mL
Phase 1 N=30 ATX Study:A Study of Avastin (Bevacizumab), Tarceva (Erlotinib) and Xeloda (Capecitabine) in Patients With Locally Advanced and/or Metastatic Pancreatic Cancer
Pancreatic Cancer
Primary: Part 1: Maximum Tolerated Dose (MTD) of Capecitabine — 900 mg/m^2 BID
Phase 1 N=32 High-Dose 131I-MIBG Therapy Combined With Vincristine and Five Days of Irinotecan for Resistant/Relapsed Neuroblastoma
Neuroblastoma
Primary: Number of Participants With Dose-limiting Toxicity as a Measure of Tolerability — 0; 0 participants with DLT
Phase 1 N=20 Characteristics of Glargine in Type 2 Diabetics
Type 2 Diabetes
Primary: Maximum Glucose Infusion Rate — 0.3; 2.6; 5.5; 6.8 umol/kg/min — p=<0.05
Phase 1 N=34 Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone
Hepatitis C
Primary: R-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9. — 6990; 5920 [ng*h/mL] — p=0.1638
Phase 1 N=29 Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers
Healthy
Primary: Group A - Efavirenz: Cmax — 771.0; 809.0 nmol/L
Phase 1 N=25 Pharmacokinetics of Faldaprevir of Soft Capsule
Healthy
Primary: Cmax,ss (After Multiple Dosing) — 3270; 14200 ng/mL
Phase 1 N=16 Drug-drug Interaction of BI 201335 and Microgynon
Hepatitis C, Chronic
Primary: AUCt,ss of Ethinylestradiol — 1010; 1450 pg*h/mL
Phase 1 N=25 Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir
Healthy
Primary: AUC( Tau,ss) — 4070; 11100 ng*h/mL — p=0.9999
Phase 1 N=51 Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin
Healthy
Primary: AUCτ,ss (Itraconazole Part) — 29900; 59500 ng*h/mL
Phase 1 N=14 Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers
HIV Infections
Primary: AUCτ,ss of Darunavir — 57200; 66000 ng*h/mL