Clinical trials: Pharmacologic Action
Healthy
A Phase 1 Study of ABBV-CLS-7262, Rosuvastatin, and Digoxin in Healthy Subjects
This study follows an open-label, single arm design with two periods with rosuvastatin, digoxin and ABBV-CLS-7262
- Trial name
- NCT05763459
- Testing
- ABBV-CLS-7262
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Calico Life Sciences LLC
Lung Cancer, Non-small Cell Lung Cancer
Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)
1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or…
- Trial name
- HER3-Lung (NCT02134015)
- Testing
- Patritumab, Erlotinib
- Where
- 98 sites in United States, Belgium and 8 more
- Volunteers
- 145 people
- Sponsor
- Daiichi Sankyo
Male Hypogonadism
Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
- Trial name
- SOAR (NCT02081300)
- Testing
- Oral testosterone undecanoate, LPCN 1021, Topical testosterone gel 1.62 %
- Volunteers
- 315 people
- Sponsor
- Lipocine Inc.
Complicated Intra-abdominal Infection
Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.
- Trial name
- RECLAIM3 (NCT01726023)
- Testing
- Ceftazidime-avibactam, metronidazole, Meropenem
- Where
- 30 sites in China, South Korea and 1 more
- Volunteers
- 486 people
- Sponsor
- Pfizer
Chronic Hepatitis C Virus
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive…
- Trial name
- NCT01851330
- Testing
- LDV/SOF, RBV
- Where
- 52 sites in United States
- Volunteers
- 647 people
- Sponsor
- Gilead Sciences
Diabetes Mellitus, Diabetes Mellitus, Type 2
The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Disease
- Trial name
- NCT05505994
- Testing
- DWP16001, Dapagliflozin
- Where
- China
- Volunteers
- 340 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Peripheral Artery Disease (PAD)
Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR
To compare the effect of ticagrelor versus aspirin on the change in peak walking time, evaluated on the graded treadmill test, from one to 26 weeks post-revascularization in patients with peripheral artery disease who have…
- Trial name
- TI-PAD EVR (NCT02227368)
- Testing
- Ticagrelor, Comparator
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Astrocytoma, Grade IV, Giant Cell Glioblastoma
Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM
This study will find the maximum safe dose (MSD) or maximum tolerated dose (MTD) of CYNK-001 which are NK cells derived from human placental CD34+ cells and culture-expanded.
- Conditions
- Astrocytoma, Grade IV, Giant Cell Glioblastoma, Glioblastoma Multiforme, Cyclophosphamide
- Trial name
- CYNK001GBM01 (NCT04489420)
- Testing
- CYNK001-IV, CYNK001-IT
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Celularity Incorporated
Diabetic Macular Edema
Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema
The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres®) using the Oxulumis®…
- Trial name
- OXEYE (NCT05697809)
- Testing
- OXU-001, Semi-automated suprachoroidal illuminated microcatheter, Ozurdex® Ophthalmic Intravitreal Implant
- Where
- 9 sites in United States, Puerto Rico
- Volunteers
- 3 people
- Sponsor
- Oxular Limited
Hereditary Angioedema (HAE)
Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers
This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of icatibant administered to adult Japanese subjects.
- Trial name
- NCT02045264
- Testing
- Icatibant (30 mg)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shire
Hypogonadism
Oral Testosterone for the Treatment of Hypogonadism in Males
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors.
- Trial name
- NCT02222558
- Testing
- TSX-002
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- TesoRx Pharma, LLC
Solid Tumor, Non-Small Cell Lung Cancer
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in…
- Conditions
- Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Melanoma
- Trial name
- NCT04198766
- Testing
- INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab 200 mg, pembrolizumab 400 mg
- Where
- 42 sites in United States, Singapore and 2 more
- Volunteers
- 340 people
- Sponsor
- Inhibrx Biosciences, Inc
Alpha 1 Antitrypsin Deficiency
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
This study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein.
- Trial name
- SWIFT-SC (NCT07555483)
- Testing
- Alpha-1 15%, Liquid Alpha1-PI
- Where
- 22 sites in United States, Denmark and 7 more
- Volunteers
- 40 people
- Sponsor
- Grifols Therapeutics LLC
Colorectal Cancer
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine…
- Trial name
- NCT00838578
- Testing
- KRN330, Irinotecan
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Pneumonia, Bacterial
Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and / or Gram-positive Bacterial Colonization
To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin Fosfomycin Inhalation System (AFIS) versus aerosolized placebo in mechanically ventilated patients with Gram-negative and / or Gram-positive bacterial…
- Trial name
- NCT02218359
- Testing
- Amikacin Fosfomycin Inhalation Solution
- Sponsor
- Cardeas Pharma
Infantile Hemangioma
Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo
There is an unsatisfied medical need for a first-line treatment of localized uncomplicated proliferating Infantile Hemangioma with a good benefit/risk profile.
- Trial name
- NCT01512173
- Testing
- propranolol gel
- Where
- 17 sites in France, Poland and 1 more
- Volunteers
- 82 people
- Sponsor
- Pierre Fabre Dermatology
Malignant Solid Tumor, Lymphomas
A Phase 1 Dose-Escalation Study in Advanced Solid Tumors, Lymphomas or Multiple Myeloma
Phase 1 study to determine safety, tolerability, dose-limiting toxicities (DLTs), and recommended Phase 2 dose of AV-299 administered IV as monotherapy to patients with relapsed or refractory solid tumors, lymphoma, or multiple…
- Conditions
- Malignant Solid Tumor, Lymphomas, Multiple Myeloma
- Trial name
- P05538 (NCT00725634)
- Testing
- AV-299, AV-299 + erlotinib
- Where
- 3 sites in United States
- Volunteers
- 41 people
- Sponsor
- AVEO Pharmaceuticals, Inc.
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
Advanced Non-squamous Non-small-cell Lung Cancer, Advanced Squamous Non-Small Cell Lung Carcinoma
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
This Phase 2, open-label, randomized study in non-small-cell lung cancer (NSCLC) is designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet…
- Conditions
- Advanced Non-squamous Non-small-cell Lung Cancer, Advanced Squamous Non-Small Cell Lung Carcinoma, Metastatic Non-squamous Non Small Cell Lung Cancer, Metastatic Squamous Non-Small Cell Lung Carcinoma
- Trial name
- VIRO-25 (NCT06463665)
- Testing
- Olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC
- Where
- 15 sites in United States
- Volunteers
- 142 people
- Sponsor
- Genelux Corporation
Influenza, Human
A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza
The purpose of this study is to test the safety and efficacy of zanamivir given intravenously and how well it works at two different doses in hospitalized adolescents and adults with flu.
- Trial name
- ZORO (NCT01231620)
- Testing
- Zanamivir, Oseltamivir
- Where
- 170 sites in United States, Australia and 26 more
- Volunteers
- 626 people
- Sponsor
- GlaxoSmithKline