Clinical trials: Molecular Mechanisms of Pharmacological Action
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
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
Suicide, Depressive Disorder, Treatment-Resistant
Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression
Background: Major depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective.
- Conditions
- Suicide, Depressive Disorder, Treatment-Resistant, Ketamine, Molecular Mechanisms of Pharmacological Action
- Trial name
- NCT06511908
- Testing
- (2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- National Institute of Mental Health (NIMH)
Molecular Mechanisms of Pharmacological Action, Depression
Effects of Acute Prucalopride Administration in Healthy Volunteers
This study will investigate whether administration of a single dose of the serotonin receptor subtype 4 (5-HT4) partial agonist prucalopride has effects on emotional processing and non-emotional cognition in healthy volunteers…
- Conditions
- Molecular Mechanisms of Pharmacological Action, Depression, Depressive Disorder, Mood Disorders
- Trial name
- NCT03863366
- Testing
- Prucalopride
- Where
- United Kingdom
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- University of Oxford
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
Prader-Willi Syndrome, Aggression
Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome
This is a placebo-controlled clinical trial to assess whether Guanfacine Extended Release (GXR) reduces aggression and self injurious behavior in individuals with Prader Willi Syndrome (PWS).
- Conditions
- Prader-Willi Syndrome, Aggression, Self-Injurious Behavior, Pathologic Processes
- Trial name
- PWS-GXR (NCT05657860)
- Testing
- Guanfacine Extended Release
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Maimonides Medical Center
Post-transplant Hepatitis C
Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C
This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options.
- Trial name
- NCT01779518
- Testing
- Sofosbuvir, Ribavirin, Pegylated Interferon
- Sponsor
- Gilead Sciences
Breast Cancer; HER2-positive; Metastatic
Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)
The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2…
- Trial name
- NCT04784715
- Testing
- Trastuzumab deruxtecan, Taxane, Pertuzumab
- Where
- 283 sites in United States, Argentina and 25 more
- Volunteers
- 1,157 people
- Sponsor
- AstraZeneca
Schizophrenia, Psychotic Disorders
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
This is a randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration.
- Conditions
- Schizophrenia, Psychotic Disorders, Mood Disorders, Schizophrenia Spectrum and Other Psychotic Disorders
- Trial name
- NCT05321602
- Testing
- LY03010 156 mg treatment group, deltoid, LY03010 156 mg treatment group, gluteal, LY03010 351 mg treatment group, deltoid
- Where
- 9 sites in United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Hepatitis C Virus Infection
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection
The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir…
- Trial name
- NCT02185794
- Testing
- Voxilaprevir, SOF/VEL
- Where
- 11 sites in United States, Puerto Rico
- Volunteers
- 101 people
- Sponsor
- Gilead Sciences
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
Healthy
A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants
The purpose of the study was to understand the effect of PF-07081532 on the movement of Dabigatran and Rosuvastatin into, though, and out of the body in healthy overweight or obese adult participants.
- Trial name
- NCT05788328
- Testing
- Dabigatran etexilate (DE), Rosuvastatin, PF-07081532
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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
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
Chronic Hepatitis C Virus
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects…
- Trial name
- ION-2 (NCT01768286)
- Testing
- LDV/SOF, RBV
- Where
- 53 sites in United States
- Volunteers
- 441 people
- Sponsor
- Gilead Sciences
Hypotension, Anesthesia; Adverse Effect, Spinal and Epidural
ONDANSETRON AND EFFECTIVE DOSE IN 50% OF SUBJECTS OF PROPHYLACTIC NOREPINEPHRINE INFUSIONS FOR PREVENTING SPINAL ANESTHESIA-INDUCED HYPOTENSION DURING CESAREAN DELIVERY
Spinal anesthesia is the preferred technique for elective cesarean section as per ASA guidelines. Hypotension is the main complication of this technique and is secondary to both sympatholysis and its associated decrease in…
- Conditions
- Hypotension, Anesthesia; Adverse Effect, Spinal and Epidural, Cesarean Section
- Trial name
- NCT04703088
- Testing
- Ondansetron 4 MG, 0.9% Saline
- Volunteers
- 60 people
- Sponsor
- Laval University
Behavioral Symptoms, Suicide
Natural History of Depression, Bipolar Disorder and Suicide Risk
Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments.
- Conditions
- Behavioral Symptoms, Suicide, Self-Injurious Behavior, Sensory System Agents
- Trial name
- NCT06462196
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- National Institute of Mental Health (NIMH)
Testicular Neoplasms, Neoplasms, Germ Cell and Embryonal
Avelumab in Refractory Testicular Germ Cell Cancer.
This is a proof-of-concept study to define efficacy of AVELUMAB in patients with multiple relapsed/refractory germ cell tumors (GCTs).
- Conditions
- Testicular Neoplasms, Neoplasms, Germ Cell and Embryonal, Neoplasms, Testicular Diseases
- Trial name
- NCT03403777
- Testing
- Avelumab
- Where
- Slovakia
- Volunteers
- 8 people
- Sponsor
- National Cancer Institute, Slovakia
Prostate Cancer
PET/CT Imaging Study of the Safety and Diagnostic Performance of [68Ga]RM2 in Patients With Primary Prostate Cancer
The aim of this study is to investigate safety and diagnostic performance of the 68Ga labeled PET tracer [68Ga]RM2 for detection and localization of primary prostate cancer confirmed by histopathology of the prostate as a…
- Trial name
- NCT02483884
- Testing
- [68Ga]RM2, PET/CT
- Where
- 2 sites in Austria, Finland
- Volunteers
- 30 people
- Sponsor
- Lantheus Biosciences Ltd.