Clinical trials: Safety and Tolerability
Healthy Adult Subjects
A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants
Rationale: Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05.
- Trial name
- NCT05632211
- Testing
- AVT05, Simponi
- Where
- 2 sites in New Zealand, United Kingdom
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Clostridium Difficile-associated Diarrhea
Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT01591863
- Testing
- fidaxomicin
- Volunteers
- 38 people
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Acute Lung Injury, Acute Respiratory Distress Syndrome
Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II
The purpose of this study was to assess the safety, tolerability and preliminary efficacy of FP-1201 (Interferon Beta) in patients with Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).
- Trial name
- NCT00789685
- Testing
- Interferon Beta
- Where
- 8 sites in United Kingdom
- Volunteers
- 37 people
- Sponsor
- Faron Pharmaceuticals Ltd
Pneumococcal Infection
Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)
The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well tolerated and produces an immune response in older adults.
- Trial name
- NCT00560950
- Testing
- pneumococcal 23v polysaccharide vaccine
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pulmonary Disease, Chronic Obstructive
Safety, Tolerability and Pharmacokinetics (PK) Study of GSK2269557 in Healthy Subjects
GSK2269557 is being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airways diseases.
- Trial name
- NCT03189589
- Testing
- GSK2269557 500 µg, GSK2269557 750 µg
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Urinary Tract Infection
Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)
The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9…
- Trial name
- NCT01014013
- Testing
- ertapenem sodium (MK0826), Comparator: ceftriaxone sodium
- Volunteers
- 271 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058)
This is a two-part study of grazoprevir (MK-5172) + elbasvir (MK-8742) in Japanese participants with chronic hepatitis C virus (HCV) genotype 1 (GT1).
- Trial name
- NCT02203149
- Testing
- Grazoprevir, Elbasvir
- Volunteers
- 399 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Volunteers
A Study of LY3006072 in Healthy Participants
The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body…
- Trial name
- NCT01640249
- Testing
- LY3006072
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
SARS-CoV-2 Infection, COVID-19
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and…
- Trial name
- NCT04816643
- Testing
- Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg
- Where
- 128 sites in United States, Brazil and 4 more
- Volunteers
- 11,837 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Multiple Sclerosis
Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis
Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain…
- Trial name
- NCT00053417
- Testing
- 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP), 15 mg fampridine-SR (4-aminopyridine, 4-AP), 20 mg fampridine-SR (4-aminopyridine, 4-AP)
- Where
- 25 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- Acorda Therapeutics
Schizophrenia
A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia
This is a Phase 2, randomized, double-blinded, placebo-controlled, inpatient study to examine the efficacy, safety, and tolerability profile of KarXT in adult subjects diagnosed with DSM-5 schizophrenia who are in an acute…
- Trial name
- EMERGENT-1 (NCT03697252)
- Testing
- Xanomeline and Trospium Chloride Capsules
- Where
- 12 sites in United States
- Volunteers
- 182 people
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Healthy
Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
Compare the DHE pharmacokinetic profiles observed following administration of: 1. MAP0004 (oral inhalation DHE) 2. MAP0004 co-administered with oral Ketoconazole 3.
- Trial name
- NCT01468558
- Testing
- MAP0004, IV DHE, Ketoconazole
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Allergan
Healthy Participants
A Study to Assess the Safety and Tolerability of Single and Multiple Ascending Doses of Oral RO7020531 in Chinese Healthy Participants.
To evaluate the safety and tolerability of single and multiple ascending doses of oral RO7020531 in Chinese healthy participants.
- Trial name
- NCT03530917
- Testing
- RO7020531
- Where
- Hong Kong
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Major Depressive Disorder (MDD)
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an…
- Trial name
- NCT01111552
- Testing
- Escitalopram, Aripiprazole
- Where
- 60 sites in United States, Australia and 5 more
- Volunteers
- 237 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Depressive Disorder, Major
A Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy
The purpose of this study is to assess the efficacy of flexibly dosed JNJ-42847922 (20 milligram [mg] or 40 mg) compared to flexibly dosed quetiapine extended-release (XR) (150 mg or 300 mg) as adjunctive therapy to an…
- Trial name
- NCT03321526
- Testing
- JNJ-42847922, Quetiapine XR, Selective Serotonin Reuptake Inhibitor (SSRI)
- Where
- 50 sites in United States
- Volunteers
- 107 people
- Sponsor
- Janssen Research & Development, LLC
Acute-graft-versus-host Disease, aGVHD
A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of EQ001 in subjects with Acute Graft Versus Host Disease (aGVHD).
- Conditions
- Acute-graft-versus-host Disease, aGVHD, GVHD, GVHD, Acute
- Trial name
- EQUATE (NCT03763318)
- Testing
- EQ001
- Where
- 16 sites in United States
- Volunteers
- 30 people
- Sponsor
- Biocon Limited
Hepatitis C
A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)
This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants.
- Trial name
- NCT00998985
- Testing
- Grazoprevir
- Volunteers
- 91 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)
Primary Objective: To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to…
- Trial name
- NCT02476006
- Testing
- ALIROCUMAB SAR236553 (REGN727), ezetimibe, atorvastatin
- Where
- 153 sites in Austria, Belgium and 14 more
- Volunteers
- 998 people
- Sponsor
- Sanofi
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
The purpose of this study is to determine the effect of TAK-925 after a single intravenous dose (compared to placebo) on promoting wakefulness as measured by sleep latency on the maintenance of wakefulness (MWT) in sleep-deprived…
- Trial name
- NCT03522506
- Testing
- TAK-925, Modafinil
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Takeda
Carcinoma, Renal Cell, Advanced, Lymphoma, Mantle-Cell
Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]
The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent /…
- Conditions
- Carcinoma, Renal Cell, Advanced, Lymphoma, Mantle-Cell, Gastrointestinal Stroma Tumors
- Trial name
- STAR-TOR (NCT00700258)
- Testing
- Temsirolimus, Sunitinib, Axitinib
- Where
- 77 sites in Germany
- Volunteers
- 1,520 people
- Sponsor
- Pfizer
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