Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules
NCT01170975 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2012-07-24
Summary
This study explores the effects of food (a high-fat meal) on the pharmacokinetics of tesetaxel.
Conditions
Interventions
- DRUG
-
Tesetaxel 10 mg with and then without food
Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state
- DRUG
-
Tesetaxel 10 mg without and then with food
Treatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state
Sponsors & Collaborators
-
Genta Incorporated
lead INDUSTRY
Principal Investigators
-
Harry W Alcorn, PharmD · Davita Clinical Research
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2011-02-28
- Completion
- 2011-04-30
Countries
- United States
Study Locations
More Related Trials
-
Study of the Mass Balance of Oral FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors
NCT02031055 ·Status: COMPLETED ·Phase: PHASE1
-
Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer
NCT05921149 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Study to Evaluate the Effect of Food on the Pharmacokinetics (PK) of TAK-659 in Participants With Advanced Solid Tumor
NCT03359733 ·Status: WITHDRAWN ·Phase: PHASE1
-
Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors
NCT01155713 ·Status: COMPLETED ·Phase: PHASE1
-
Toxicity & Pharmacokinetics of 2 & 3-weekly Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
NCT03343977 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
IMP4297 Food Effect Trial in Healthy Volunteers
NCT04057729 ·Status: COMPLETED ·Phase: PHASE1
-
The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
NCT03892018 ·Status: TERMINATED ·Phase: PHASE1
-
Food Effect Study of D-0502 Tablet in Healthy Volunteers
NCT03810625 ·Status: COMPLETED ·Phase: PHASE1
-
Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer
NCT01175837 ·Status: COMPLETED ·Phase: NA
-
BA Study of IMP4297 (20mg vs 10mg) in Healthy Male Subjects
NCT04351165 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
NCT01537029 ·Status: COMPLETED ·Phase: PHASE4
-
1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors
NCT01191216 ·Status: COMPLETED ·Phase: PHASE1
-
D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours
NCT01851265 ·Status: COMPLETED ·Phase: PHASE1
-
Docetaxel in Treating Patients With Solid Tumors
NCT00003565 ·Status: COMPLETED ·Phase: PHASE2
-
To Determine the Effect of Food on the Pharmacokinetics of Olaparib and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation in Patients With Advanced Solid Tumours
NCT01921140 ·Status: COMPLETED ·Phase: PHASE1
-
Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer
NCT00905658 ·Status: UNKNOWN ·Phase: PHASE2
-
A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors
NCT00046111 ·Status: COMPLETED ·Phase: PHASE1
-
An Open Label Study to Examine the Effects of a High-Fat Meal and Particle Size on the Pharmacokinetics of Orally Administered GSK2118436 in Subjects With BRAF Mutation Positive Tumor
NCT01231568 ·Status: COMPLETED ·Phase: PHASE1
-
Food Effect Study on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects
NCT05528120 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of Dactinomycin in Young Patients With Cancer
NCT00900354 ·Status: UNKNOWN
-
Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer
NCT06671613 ·Status: RECRUITING ·Phase: NA
-
Pharmacokinetics of Daunorubicin in Young Patients With Cancer
NCT00673257 ·Status: COMPLETED ·Phase: NA
-
A Pharmacokinetic Study of Oral Cyclophosphamide and Topotecan in Children With Recurrent Solid Tumors
NCT00628732 ·Status: COMPLETED ·Phase: PHASE2
-
Oral Topotecan to Treat Recurrent or Persistent Solid Tumors
NCT00382733 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study Comparing Oral Picoplatin With Intravenous Picoplatin in Subjects With Solid Tumors
NCT00465725 ·Status: COMPLETED ·Phase: PHASE1