Clinical trials: Physiological Effects of Drugs
Breast Cancer, Solid Tumors, Adult
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid…
- Trial name
- PIKALO-1 (NCT05768139)
- Testing
- STX-478, Fulvestrant, Ribociclib
- Where
- 65 sites in United States, Belgium and 7 more
- Volunteers
- 880 people
- Sponsor
- Eli Lilly and Company
Multiple Myeloma, Neoplasm, Plasma Cell
Natural Killer Cell (CYNK-001) Infusions in Adults With Multiple Myeloma
This study will find the maximum tolerated dose (MTD) of CYNK-001 which contain NK cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given post Autologous Stem Cell Transplant (ASCT).
- Conditions
- Multiple Myeloma, Neoplasm, Plasma Cell, Neoplasms by Histologic Type, Neoplasms
- Trial name
- NCT04309084
- Testing
- CYNK-001
- Where
- 4 sites in United States
- Volunteers
- 29 people
- Sponsor
- Celularity Incorporated
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
Coronary Artery Disease
ABSORB PHYSIOLOGY Clinical Investigation
The target enrollment goal for the trial was to enroll 36 subjects. However due to a challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the trial was initiated in June 2011.
- Trial name
- NCT01308346
- Testing
- Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS), XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
- Where
- 6 sites in Australia, China and 2 more
- Volunteers
- 1 people
- Sponsor
- Abbott Medical Devices
Achondroplasia
An Extension Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia
The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia
- Trial name
- NCT03424018
- Testing
- BMN 111
- Where
- 24 sites in United States, Australia and 5 more
- Volunteers
- 119 people
- Sponsor
- BioMarin Pharmaceutical
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.
Brain Edema, Stroke, Acute
Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction
The primary objective of Part 1 of the study is to determine if BIIB093 improves functional outcome at Day 90 as measured by the modified Rankin Scale (mRS) when compared with placebo in participants with Large Hemispheric…
- Trial name
- CHARM (NCT02864953)
- Testing
- BIIB093
- Where
- 250 sites in United States, Australia and 22 more
- Volunteers
- 535 people
- Sponsor
- Remedy Pharmaceuticals, Inc.
Type 2 Diabetes Mellitus
A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)
This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in participants with type 2 diabetes mellitus.
- Trial name
- NCT02004886
- Testing
- MK-0893, Metformin
- Volunteers
- 74 people
- Sponsor
- Merck Sharp & Dohme LLC
Virus Diseases, RNA Virus Infections
Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent Influenza Vaccine in Adults
A phase II trial multicenter, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular injection of plant-derived Seasonal VLP…
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Trial name
- NCT02233816
- Testing
- Low dose of quadrivalent VLP vaccine, Medium dose of quadrivalent VLP vaccine, High dose of quadrivalent VLP vaccine
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Medicago
Hodgkin Lymphoma
A Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Hodgkin Lymphoma
This phase 4, single-arm, open-label, multicenter study is designed to evaluate the efficacy and safety of brentuximab vedotin as a single agent in adult participants with histologically confirmed CD30+ relapsed or refractory…
- Trial name
- NCT01990534
- Testing
- Brentuximab Vedotin
- Where
- 18 sites in Czechia, Germany and 5 more
- Volunteers
- 60 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Encephalitis, Encephalitis, Viral
Venezuelan Equine Encephalitis Monovalent Virus-Like Particle Vaccine
The primary objective of the study is to evaluate the safety and immunogenicity of non-adjuvanted and adjuvanted monovalent VEE VLP Vaccine in healthy adults (ages 18-50 years) when administered via intramuscular (IM) injection…
- Conditions
- Encephalitis, Encephalitis, Viral, Infectious Encephalitis, Virus Diseases
- Trial name
- VEEV (NCT03776994)
- Testing
- Vaccinations on Day 0, Day 28, and Day 140
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- SRI International
Acute Pain
Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy Surgery
The purpose of this study is to determine the effectiveness and safety of single intravenous doses of the kappa opioid agonist CR845 in relieving pain in patients following laparoscopic-assisted hysterectomy surgery.
- Trial name
- NCT00877799
- Testing
- CR845
- Where
- 12 sites in United States
- Volunteers
- 114 people
- Sponsor
- Cara Therapeutics, Inc.
Type 2 Diabetes Mellitus
A Study of MK-0893 on Glucagon-Induced Glycemic Excursion in Healthy Male Participants Following Intravenous Administration of Glucagon, Sandostatine® and Insulin (MK-0893-002)
This is a study to assess the pharmacokinetics, safety, and tolerability of sequential single oral doses of MK-8093 10 mg, 40 mg, 200 mg, or placebo to MK-8093 (Part 1) depending on treatment assignment in young healthy male…
- Trial name
- NCT02012166
- Testing
- MK-0893 10 mg, MK-0893 40 mg, MK-0893 200 mg
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Virus Diseases, RNA Virus Infections
Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine in Healthy Adults
This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies.
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Trial name
- NCT02768805
- Testing
- 15 µg/strain of Quadrivalent VLP Vaccine, 30 µg/strain of Quadrivalent VLP Vaccine, 15 µg/strain of the licensed quadrivalent vaccine
- Where
- 9 sites in United States, Canada
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Medicago
Achondroplasia
A Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia
The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia.
- Trial name
- NCT03197766
- Testing
- BMN 111
- Where
- 24 sites in United States, Australia and 5 more
- Volunteers
- 121 people
- Sponsor
- BioMarin Pharmaceutical
Eosinophilic Esophagitis
A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants…
- Trial name
- NCT04753697
- Testing
- CC-93538
- Where
- 212 sites in United States, Argentina and 13 more
- Volunteers
- 430 people
- Sponsor
- Celgene
Advanced Cancer, Cervical Cancer
A Study of AGEN2034 in Advanced Tumors and Cervical Cancer
This is a 2-part trial: a Phase 1, open-label, dose-escalation study in participants with metastatic or locally advanced solid tumors, with a consecutive Phase 2 expansion to evaluate efficacy in participants with recurrent…
- Trial name
- NCT03104699
- Testing
- AGEN2034
- Where
- 44 sites in United States, Australia and 7 more
- Volunteers
- 211 people
- Sponsor
- Agenus Inc.
COVID-19
Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)
The purpose of the study is to determine if a high dose of Intravenous Immune Globulin (IVIG) plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19…
- Trial name
- NCT04480424
- Testing
- GAMUNEX-C, Standard Medical Treatment
- Where
- 18 sites in United States
- Volunteers
- 100 people
- Sponsor
- Grifols Therapeutics LLC
Achondroplasia
Study to Evaluate the Efficacy and Safety of BMN 333 Versus Vosoritide in Children With Achondroplasia
This is a multicenter, multinational, randomized, active-controlled, operationally seamless Phase 2/3 study of BMN 333 in treatment-naïve pediatric participants with achondroplasia (ACH).
- Trial name
- ASPEN (NCT07441876)
- Testing
- BMN 333, Vosoritide Injection [Voxzogo]
- Where
- 28 sites in United States, Australia and 7 more
- Volunteers
- 160 people
- Sponsor
- BioMarin Pharmaceutical
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