Clinical trials: Safety Study
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated
The main objectives of this trial are to investigate (1) safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising doses of BI 1569912; (2) tolerability of BI 1569912 in an up-titrating dosing scheme.
- Trial name
- NCT04978506
- Testing
- BI 1569912
- Where
- Germany
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Pancreatic Cancer
Study of Ruxolitinib in Pancreatic Cancer Patients
The purpose of this study was to determine whether ruxolitinib added to capecitabine is effective in improving the overall survival of patients with metastatic pancreatic cancer.
- Trial name
- RECAP (NCT01423604)
- Testing
- Capecitabine, Ruxolitinib
- Where
- 39 sites in United States
- Volunteers
- 136 people
- Sponsor
- Incyte Corporation
Primary Mitochondrial Disease
Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)
This is a Phase 2 Open-Label extension study to evaluate the long term safety and tolerability of daily elamipretide injections in patients with genetically confirmed Primary Mitochondrial Disease who previously participated in…
- Trial name
- NCT02976038
- Testing
- elamipretide
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- Stealth BioTherapeutics Inc.
Respiratory Syncytial Virus (RSV)
A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults
The purpose of this study is to determine if the administration of single ascending intramuscular doses of the RSV sF antigen or MEDI7510 will be safe and well tolerated in adults 60 years or older who are healthy or who have…
- Trial name
- NCT02115815
- Testing
- RSV sF 20 mcg, MEDI7510 (20 mcg RSV sF), RSV sF 50 mcg
- Where
- 3 sites in United States
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Prostate Cancer
Evaluation of Safety and Feasibility of OGX-011 in Combination With 2nd-line Chemotherapy in Patients With HRPC
This study is for patients with cancer of the prostate gland that has metastasized or spread outside the prostate to other parts of the body.
- Trial name
- NCT00327340
- Testing
- custirsen (OGX-011)/mitoxantrone, custirsen (OGX-011)/docetaxel
- Where
- 10 sites in Canada
- Volunteers
- 70 people
- Sponsor
- Achieve Life Sciences
Chronic Hepatitis B
Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
The objective of this 96-week study was to evaluate the safety and antiviral efficacy of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without hepatitis B immunoglobulin (HBIg) in…
- Trial name
- NCT00507689
- Testing
- FTC/TDF, Hepatitis B Immunoglobulin (HBIg)
- Where
- 7 sites in United States
- Volunteers
- 40 people
- Sponsor
- Gilead Sciences
Breast Cancer
Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) for the treatment of pre…
- Trial name
- AMALEE (NCT03822468)
- Testing
- Ribociclib, Anastrozole, Letrozole
- Where
- 89 sites in United States, Argentina and 21 more
- Volunteers
- 376 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Participants
A Sub Study to Evaluate the Study Medication (Etrasimod) Using Wearable Sensors in Healthy Participants
The purpose of this study is to look at how healthy adults process Etrasimod when assessed by wearable sensors. Etrasimod is taken without food and assessments taken by site staff and then by participants after training.
- Trial name
- NCT06140290
- Testing
- Etrasimod Immediate Release (IR)
- Where
- Belgium
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
HIV-1-infection
Study of VRC07-523LS, CAP256V2LS, and Vesatolimod, in Early Antiretroviral-treated HIV-1 Clade C-infected Women
The goals of this clinical study are to learn more about the study drugs, VRC07-523LS, CAP256V2LS, and vesatolimod (VES) and how safe it is in women that have HIV and are on antiretroviral therapy (ART).
- Trial name
- NCT05281510
- Testing
- Vesatolimod, VRC07523LS, CAP256V2LS
- Where
- South Africa
- Volunteers
- 20 people
- Sponsor
- Gilead Sciences
Uncontrolled Gout
Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy
This is a Phase 4, multicenter, open-label trial of pegloticase with methotrexate (MTX) in adult participants with uncontrolled gout who were previously treated with pegloticase without a concomitant immunomodulator and stopped…
- Trial name
- NCT04772313
- Testing
- Pegloticase, Methotrexate (MTX)
- Where
- 15 sites in United States
- Volunteers
- 11 people
- Sponsor
- Amgen
Acute Myeloid Leukemia
A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia
To compare disease-free survival in patients 60 years or older with acute myeloid leukemia (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.
- Trial name
- NCT01961882
- Testing
- OCV-501
- Where
- 14 sites in Japan, South Korea and 1 more
- Volunteers
- 134 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Skin Aging of Dorsal Hands
Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lido and Vital Without Lido in Dorsal Hand
This is a randomized, multi-center, split-hand, subject-blinded study comparing pain, safety and effectiveness of Restylane Skinboosters Vital Lidocaine and Restylane Vital without lidocaine for improving appearance of the dorsal…
- Trial name
- NCT06372782
- Testing
- Restylane Skinboosters Vital Lidocaine, Restylane Vital
- Where
- 3 sites in China
- Volunteers
- 90 people
- Sponsor
- Galderma R&D
Acute Myeloid Leukemia (AML)
Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML
This trial will evaluate whether luveltamab tazevibulin is well tolerated and active against a rare form of AML carrying a particular genetic abnormality called CBFA2T3::GLIS2 that arises in infants and children.
- Trial name
- NCT06679582
- Testing
- Luveltamab tazevibulin
- Where
- 36 sites in United States, Austria and 7 more
- Volunteers
- 1 people
- Sponsor
- Sutro Biopharma, Inc.
Schizophrenia
Study Evaluating Vabicaserin in Subjects With Schizophrenia
The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.
- Trial name
- NCT00563706
- Testing
- vabicaserin, risperidone
- Where
- 33 sites in United States, Canada
- Volunteers
- 199 people
- Sponsor
- Pfizer
Adult Growth Hormone Deficiency, Endocrine System Diseases
A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
This was a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly.
- Conditions
- Adult Growth Hormone Deficiency, Endocrine System Diseases, Hormone Deficiency
- Trial name
- NCT05171855
- Testing
- Lonapegsomatropin
- Where
- 85 sites in United States, Armenia and 19 more
- Volunteers
- 220 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Diabetes Mellitus, Type 2
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.
- Trial name
- NCT01422876
- Testing
- high dose FDC, BI 10773 high dose
- Where
- 211 sites in United States, Argentina and 20 more
- Volunteers
- 1,405 people
- Sponsor
- Boehringer Ingelheim
Huntington Disease
A Study to Evaluate the Safety and Efficacy of PTC518 in Participants With Huntington's Disease (HD)
The primary goal of this study is to evaluate the safety and pharmacodynamic effects of PTC518 compared with placebo in participants with HD.
- Trial name
- NCT05358717
- Testing
- PTC518
- Where
- 28 sites in United States, Australia and 9 more
- Volunteers
- 159 people
- Sponsor
- Novartis Pharmaceuticals
Overactive Bladder
Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia
This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment…
- Trial name
- NCT04103450
- Testing
- Vibegron
- Where
- 35 sites in United States, Poland
- Volunteers
- 276 people
- Sponsor
- Urovant Sciences GmbH
Thrombocytopenia, Neutropenia
Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
This research study will investigate the safety and effectiveness of two different dose levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine and carboplatin or gemcitabine and cisplatin…
- Conditions
- Thrombocytopenia, Neutropenia, Lymphopenia, Anemia
- Trial name
- NCT00771810
- Testing
- TXA127
- Where
- 6 sites in United States
- Volunteers
- 34 people
- Sponsor
- Tarix Pharmaceuticals
Advanced Solid Tumors
Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors
This is a first-in-human, Phase I, multicenter, open label, dose escalation study to evaluate the DLTs and MTD and to determine the recommended Phase 2 dose (RP2D) of CPX-POM administered IV in patients with any histologically…
- Trial name
- NCT03348514
- Testing
- CPX-POM - 30 mg/m^2, CPX-POM - 60 mg/m^2, CPX-POM - 120 mg/m^2
- Where
- 5 sites in United States
- Volunteers
- 19 people
- Sponsor
- CicloMed LLC
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