Clinical trials: Safety and Tolerability
Respiratory Syncytial Viruses
A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease
The purpose of this two-part designed study is to assess in the setting of a planned early interception of pediatric RSV disease, early viral and disease kinetics (observational stage) and the antiviral effects of an Respiratory…
- Trial name
- NCT04068792
- Testing
- RSV Mobile Application, JNJ-53718678 2.5 mg/kg, JNJ-53718678 3 mg/kg
- Where
- 10 sites in Argentina, Belgium and 3 more
- Volunteers
- 22 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 1015550 Are Taken up in the Body and How Well They Are Tolerated.
The primary objective of this trial is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of single rising doses.
- Trial name
- NCT03542344
- Testing
- BI 1015550 6 mg
- Where
- Japan
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatitis C
An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before.
- Trial name
- QUEST-2 (NCT01290679)
- Testing
- TMC435, Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b), Ribavirin (RBV)
- Where
- 60 sites in United States, Argentina and 13 more
- Volunteers
- 393 people
- Sponsor
- Janssen R&D Ireland
Dry Eye Disease
Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.
To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.
- Trial name
- NCT04362670
- Testing
- OTX-CSI
- Where
- 15 sites in United States
- Volunteers
- 153 people
- Sponsor
- Ocular Therapeutix, Inc.
Migraine
Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine
A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms.
- Trial name
- ATO-TOPIRAMATE (NCT05748483)
- Testing
- Atogepant, Topiramate
- Where
- 81 sites in Austria, Belgium and 10 more
- Volunteers
- 545 people
- Sponsor
- AbbVie
Migraine Disorders, Chronic Disease
"Follow the Sutures". A New Procedure for Injection of Botulinum Toxin for Chronic Migraine
There is no doubt that chronic migraine is a large public health problem, which is both disabling and costly. Many patients and headache doctors see Botulinum toxin (Botox) treatment as a big stride forward, but it is a problem…
- Trial name
- NCT03543254
- Testing
- BoNT-A
- Where
- Norway
- Volunteers
- 20 people
- Sponsor
- Norwegian University of Science and Technology
Atrial Fibrillation, Atrial Flutter
Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter
The primary purpose of this study is to optimize drug exposure in the target population.
- Trial name
- NCT01229254
- Testing
- Amiodarone, Betrixaban 60 mg, Betrixaban 90 mg
- Volunteers
- 189 people
- Sponsor
- Portola Pharmaceuticals
Hepatitis A, Measles
Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine Live will be given concomitantly or non-concomitantly.
- Conditions
- Hepatitis A, Measles, Mumps, Rubella
- Trial name
- NCT00326183
- Testing
- VAQTA®, ProQuad
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Narcolepsy
An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy
The rationale for the interventional, open-label, single-arm design of JZP258-401 is to evaluate the clinical experience in participants with narcolepsy transitioning treatment from Xyrem to XYWAV.
- Trial name
- NCT04794491
- Testing
- JZP-258
- Where
- 28 sites in United States
- Volunteers
- 62 people
- Sponsor
- Jazz Pharmaceuticals
Meningococcal Disease
Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults
This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.
- Trial name
- NCT00560313
- Testing
- Men ACWY CRM, 4CMenB
- Where
- Italy
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Bipolar I Disorder
A Study of Elpipodect (MK-8189) in Participants With Bipolar I Disorder (MK-8189-020)
The goal of this study is to evaluate the safety and tolerability of elpipodect in participants with stable bipolar I disorder. There was no hypothesis testing in this study.
- Trial name
- NCT06273774
- Testing
- Elpipodect
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Merck Sharp & Dohme LLC
Bowel Incontinence
A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage
The purpose of this study is to determine whether the use of the Renew Insert is effective, tolerable and safe in the treatment of accidental bowel leakage due to bowel incontinence.
- Trial name
- REST (NCT01475474)
- Testing
- Renew Insert
- Where
- 3 sites in United States
- Volunteers
- 97 people
- Sponsor
- Renew Medical
Acute Heart Failure
Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode.
The purpose of this study was to assess the effect of in-hospital initiation of sacubitril/valsartan (LCZ696) vs. enalapril on time averaged proportional change in NT-proBNP in patients who have been stabilized following…
- Trial name
- PIONEER-HF (NCT02554890)
- Testing
- sacubitril/valsartan (LCZ696), Enalapril
- Where
- 123 sites in United States
- Volunteers
- 887 people
- Sponsor
- Novartis Pharmaceuticals
Cancer
A Study to Evaluate Safety, Tolerability and Preliminary Efficacy of FP-1305 in Cancer Patients (MATINS)
This is a first in human study to identify whether FP-1305 is suitable to use in humans. The previous pre-clinical studies have demonstrated that FP-1305 binds to a receptor known as CLEVER-1.
- Trial name
- NCT03733990
- Testing
- FP-1305 (bexmarilimab)
- Where
- 11 sites in United States, Finland and 4 more
- Volunteers
- 216 people
- Sponsor
- Faron Pharmaceuticals Ltd
Severe Alzheimer Disease
A Study to Assess the Safety of GRF6019 Infusions in Subjects With Severe Alzheimer's Disease
This study will evaluate the safety, tolerability, and potential cognitive benefit of the experimental treatment GRF6019 in subjects with severe Alzheimer's disease.
- Trial name
- NCT03765762
- Testing
- GRF6019
- Where
- 6 sites in United States
- Volunteers
- 26 people
- Sponsor
- Alkahest, Inc.
Influenza
Safety Study of CSL Limited's Influenza Virus Vaccine in the Paediatric Population Aged >= 6 Months to < 18 Years
A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18 Years
- Trial name
- NCT00825162
- Testing
- CSL Limited Influenza Virus Vaccine
- Where
- 7 sites in Australia
- Volunteers
- 1,992 people, healthy volunteers welcome
- Sponsor
- Seqirus
B-Cell Malignancies
A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)
Open-label, dose-escalation study in subjects with previously treated B-cell malignancies to find maximum tolerated dose (MTD) or pharmacologic active dose of a PI3Kδ inhibitor, parsaclisib, as monotherapy and in combination…
- Trial name
- NCT02018861
- Testing
- Parsaclisib, Itacitinib, Rituximab
- Where
- 7 sites in United States
- Volunteers
- 88 people
- Sponsor
- Incyte Corporation
Relapsed/Refractory AML, Minimal Residual Disease Positive AML
A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies
The purpose of this First-in-Human Phase 1 study is to determine if AMG 330 given as a continuous IV infusion is safe and tolerable in adult subjects that have myeloid malignancies, and to determine the maximum tolerated dose…
- Conditions
- Relapsed/Refractory AML, Minimal Residual Disease Positive AML, Myelodysplastic Syndrome
- Trial name
- NCT02520427
- Testing
- AMG 330
- Where
- 11 sites in United States, Canada and 2 more
- Volunteers
- 95 people
- Sponsor
- Amgen
Healthy
Multiple Rising Oral Dose Study of PG 760564 Administered Twice Daily to Healthy Male/Female Volunteers for 14 Days
This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).
- Trial name
- NCT00791388
- Testing
- PG-760564
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Procter and Gamble
Chronic Renal Failure, Chronic Kidney Disease
Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD (EU)
The purpose of this study was to evaluate the long term safety and tolerability of peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease (CKD) who had received at least 24 weeks of…
- Conditions
- Chronic Renal Failure, Chronic Kidney Disease, Anemia
- Trial name
- NCT00453973
- Testing
- peginesatide
- Where
- 20 sites in Bulgaria, Poland and 2 more
- Volunteers
- 114 people
- Sponsor
- Affymax
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