Clinical trials: Pharmacological Action
Major Depressive Disorder
A Study of LY03005 vs Pristiq
The objective of this study is to evaluate relative bioavailability between 80 mg LY03005 oral tablets and 50 mg Pristiq® oral tablets after a single dose of each drug in a cross-over 2-period design under fasting condition in…
- Trial name
- NCT03733574
- Testing
- LY03005, Pristiq
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Breast Neoplasms, Breast Cancer
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
- Conditions
- Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer
- Trial name
- NCT05113251
- Testing
- Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab
- Where
- 145 sites in United States, Brazil and 16 more
- Volunteers
- 927 people
- Sponsor
- AstraZeneca
Unspecified Adult Solid Tumor, Protocol Specific, Gastric Cancer
A Study of KX2-391 With Paclitaxel in Patients With Solid Tumors
The primary objective of this study is to determine the maximum tolerated dose (MTD) of KX2-391 in Combination with paclitaxel in Phase I, and to evaluate the efficacy of KX2-391 in combination with paclitaxel in patients who are…
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific, Gastric Cancer, Breast Cancer
- Trial name
- NCT01764087
- Testing
- KX2-391 and Paclitaxel
- Where
- 2 sites in South Korea
- Volunteers
- 60 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Advanced Breast Cancer
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
- Trial name
- MONALEESA-3 (NCT02422615)
- Testing
- Ribociclib, Fulvestrant
- Where
- 174 sites in United States, Australia and 28 more
- Volunteers
- 726 people
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus
A Study of the Safety and Efficacy of Omarigliptin (MK-3102) in ≥18 and <45 Year-Old Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028)
This study will examine the safety and efficacy of once-weekly omarigliptin in participants 18 to <45 years of age with Type 2 diabetes mellitus and inadequate glycemic control.
- Trial name
- NCT01814748
- Testing
- Omarigliptin, Metformin
- Volunteers
- 203 people
- Sponsor
- Merck Sharp & Dohme LLC
Rectal Cancer
Tecemotide (L-BLP25) in Rectal Cancer
The objective of this mechanistic study is to determine the impact of tecemotide (L-BLP25) administration on the mucinous glycoprotein 1 - (MUC1) specific immune response in subjects with newly diagnosed rectal cancer who are…
- Trial name
- SPRINT (NCT01507103)
- Testing
- Tecemotide (L-BLP25), cyclophosphamide (CPA), Chemoradiotherapy
- Where
- Netherlands
- Volunteers
- 124 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Carcinoma, Non-Small Cell-Lung, Lung Neoplasms
A Phase 1b/2 Study in Asian Subjects With Non-Small Cell Lung Cancer
During Phase 1b portion, there will be a dose-escalation of AV-299 (formerly SCH 900105) in combination with the recommended dose of gefitinib in subjects with NSCLC or advanced solid tumor.
- Conditions
- Carcinoma, Non-Small Cell-Lung, Lung Neoplasms, Lung Cancer, Respiratory Tract Neoplasms
- Trial name
- NCT01039948
- Testing
- AV-299 + gefitinib, Gefitinib
- Where
- 26 sites in Hong Kong, Malaysia and 5 more
- Volunteers
- 203 people
- Sponsor
- AVEO Pharmaceuticals, Inc.
Advanced Solid Tumors
A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment
Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of hepatic impairment.
- Trial name
- NCT02301104
- Testing
- TAS-102
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Taiho Oncology, Inc.
Chronic Hepatitis C Virus
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks…
- Trial name
- NCT01701401
- Testing
- LDV/SOF, RBV
- Where
- 88 sites in United States, France and 5 more
- Volunteers
- 870 people
- Sponsor
- Gilead Sciences
Infertility, In Vitro Fertilization
Investigate Dose of Org 36286 to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI (P07015)
The primary objective of this trial was to investigate the appropriate dose of a single injection of Org 36286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol…
- Trial name
- NCT00702806
- Testing
- Org 36286, Puregon®, Orgalutran®
- Volunteers
- 99 people
- Sponsor
- Organon and Co
In Vitro Fertilization
Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714)
The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated COS cycles using a multiple dose GnRH…
- Trial name
- Trust (NCT00696878)
- Testing
- Corifollitropin alfa, FSH, GnRH antagonist
- Volunteers
- 682 people
- Sponsor
- Organon and Co
Multiple Myeloma
Study of Vorinostat (MK-0683) or Placebo, in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-088 AMN)
Study of the efficacy and safety of bortezomib administered in combination with vorinostat in patients with relapsed or refractory multiple myeloma.
- Trial name
- NCT00773747
- Testing
- Vorinostat, bortezomib
- Volunteers
- 637 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Virus
Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.
- Trial name
- NCT01838590
- Testing
- SOF, RBV
- Where
- 2 sites in Egypt
- Volunteers
- 103 people
- Sponsor
- Gilead Sciences
Vasomotor Symptoms (VMS)
Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen
Open-label, two dose study of Q-122, over a 4 week treatment period to explore the effects of Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor or tamoxifen.
- Trial name
- NCT04080297
- Testing
- oral capsule of Q-122
- Volunteers
- 21 people
- Sponsor
- Que Oncology
Viral Infection
Safety and Pharmacokinetics of UV-4B Solution Administered Orally as Multiple Ascending Doses to Healthy Subjects
The purpose of this study is to evaluate the safety and pharmacokinetics of UV-4B oral solution when administered to healthy subjects three times a day (TID) for 7 days.
- Trial name
- NCT02696291
- Testing
- UV-4B 30 mg oral solution, UV-4B 75 mg oral solution, UV-4B 150 mg oral solution
- Where
- 2 sites in United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Proctitis, Proctosigmoiditis
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who…
- Trial name
- NCT01008410
- Testing
- Budesonide
- Where
- 63 sites in United States
- Volunteers
- 265 people
- Sponsor
- Bausch Health Americas, Inc.
MPN (Myeloproliferative Neoplasms)
Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)
This is a Phase IV, multicenter, non-interventional, non-randomized, prospective, observational study in an adult population (patients >18 years old) of men and women who have been diagnosed with clinically overt PV and are being…
- Trial name
- NCT02252159
- Where
- 266 sites in United States, Puerto Rico
- Volunteers
- 2,544 people
- Sponsor
- Incyte Corporation
Solid Tumor, Adult, Solid Tumor Cancer
Study of DF6215 in Patients With Advanced Solid Tumors
A Phase I/Ib, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 Monotherapy and in Combination Therapy in Patients with Advanced…
- Trial name
- NCT06108479
- Testing
- DF6215, pembrolizumab, KEYTRUDA®
- Where
- 21 sites in United States, Australia and 1 more
- Volunteers
- 35 people
- Sponsor
- Dragonfly Therapeutics
Myelodysplastic Syndromes
Study of Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes (MDS)
The primary purpose of this study is to determine the effectiveness and safety of azacitidine in the treatment of Taiwanese subjects with higher-risk Myelodysplastic Syndrome (MDS).
- Trial name
- NCT01201811
- Testing
- Azacitidine
- Where
- 11 sites in Taiwan
- Volunteers
- 44 people
- Sponsor
- Celgene
Healthy Volunteer
A Healthy Volunteer Study Evaluating the the Safety, Tolerability, and Pharmacokinetics of RT234
The objective of this two part study was to demonstrate safety, tolerability, and pharmacokinetics of RT234 in healthy volunteers.
- Trial name
- NCT05567367
- Testing
- Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI), Vardenafil Oral Tablet
- Where
- Australia
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Respira Therapeutics, Inc.