Clinical trials: Tolerability
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
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.
Chronic Obstructive Pulmonary Disease (COPD)
Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD
The purpose of this study is to evaluate discontinuation rates of roflumilast using an up-titration regimen for the first 4 weeks of treatment compared with continuous treatment of 500 μg one daily (OD) during the entire 12-week…
- Trial name
- OPTIMIZE (NCT02165826)
- Testing
- Roflumilast, Standard of Care COPD Treatment
- Where
- 2 sites in Slovakia
- Volunteers
- 1,323 people
- Sponsor
- AstraZeneca
Parkinson Disease
Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease
This study is a placebo-controlled, double-blind trial that will investigate the safety and tolerability of molecular hydrogen, a promising antioxidant agent, in patients with early-stage Parkinson's Disease.
- Trial name
- NCT03971617
- Testing
- Hydrogen
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Stony Brook University
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
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
Psoriasis
A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis
This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled, single ascending dose study GSK2831781 administered by IV.
- Trial name
- NCT02195349
- Testing
- GSK2831781
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lung Injury, Acute
The Safety, Tolerability, PK and PD of GSK2586881 in Patients With Acute Lung Injury
This is an early phase (phase IIa), randomized, multi-center study in subjects with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS).
- Trial name
- NCT01597635
- Testing
- Dose 1 GSK2586881, Dose 2 GSK2586881, Dose 3 GSK2586881
- Where
- 19 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- GlaxoSmithKline
Colitis, Crohn's Disease
NIH Substudy of AIN457 (Anti-IL-17 Monoclonal Antibody) for Treatment of Moderate to Severe Crohn's Disease
The objective of this NIH-specific substudy is immunologic monitoring of cytokine and immune cell responses in subjects undergoing treatment with AIN457 (human monoclonal anti-human interleukin-17A) for moderate to severe Crohn's…
- Conditions
- Colitis, Crohn's Disease, Inflammatory Bowel Disease
- Trial name
- NCT00936585
- Testing
- Immunologic Monitoring
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
Hypertension
Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension
The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan medoxomil, once daily (QD), in individuals with hypertension.
- Trial name
- NCT00362115
- Testing
- Azilsartan Medoxomil, Olmesartan
- Where
- 54 sites in United States, Argentina and 2 more
- Volunteers
- 449 people
- Sponsor
- Takeda
Cystic Fibrosis
Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients
Assessment of the safety, tolerability and early signs of efficacy of three times a day orally administered BAY63-2521 in adult delta F508 homozygous Cystic Fibrosis patients not on treatment with Orkambi
- Trial name
- NCT02170025
- Testing
- Riociguat (Adempas, BAY63-2521)
- Where
- 10 sites in United States, Belgium and 5 more
- Volunteers
- 21 people
- Sponsor
- Bayer
Agitation Associated With, Alzheimer's Disease
A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation
To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.
- Conditions
- Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder
- Trial name
- NCT01862640
- Testing
- Brexpiprazole, OPC-34712
- Where
- 85 sites in United States, Croatia and 5 more
- Volunteers
- 433 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Crohn's Disease
Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease
The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that…
- Trial name
- NCT01150890
- Testing
- Brodalumab
- Where
- 50 sites in United States, Australia and 6 more
- Volunteers
- 130 people
- Sponsor
- Amgen
Healthy, Chronic Stable Illness
COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers
The primary objectives of the study are: To evaluate the extent of effect, if any, of REGN10933+REGN10987 administration on vaccine-induced neutralizing antibody responses to SARS-CoV-2 by Moderna mRNA-1273 To evaluate the time…
- Trial name
- NCT04852978
- Testing
- casirivimab+imdevimab, Moderna mRNA-1273 vaccine
- Where
- 6 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
AIDS
Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine
A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combination therapy in HIV-infected…
- Trial name
- RALAM (NCT02284035)
- Testing
- Raltegravir/3TC, EFV/TDF/FTC, ATV/r + TDF/FTC or DRV/r + TDF/FTC
- Where
- Spain
- Volunteers
- 75 people
- Sponsor
- Juan A. Arnaiz
Uncomplicated Plasmodium Falciparum Malaria
Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria
This study aimed to determine the efficacy, safety and tolerability of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients (6 months to < 18 years of…
- Trial name
- KALUMI (NCT04546633)
- Testing
- KAF156, LUM-SDF, Coartem
- Where
- 9 sites in Burkina Faso, Côte d’Ivoire and 3 more
- Volunteers
- 295 people
- Sponsor
- Novartis Pharmaceuticals
Depression
Trial to Determine the Maximum Tolerated Dose (MTD) Based on Safety and Tolerability, of Org 26576 in Participants With Major Depressive Disorder (174001/P05704/MK-8777-001)
Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.
- Trial name
- NCT00610649
- Testing
- MK-8777
- Volunteers
- 54 people
- Sponsor
- Merck Sharp & Dohme LLC
Ocular Inflammation and Pain After Cataract Surgery
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
This is a Phase 2a, 2-part study (designated Parts A and B) that will evaluate APP13007 dose strength and dosing frequency in a randomized double-masked fashion for comparison to the respective matching vehicle placebo.
- Trial name
- NCT04089735
- Testing
- APP13007, 0.05%, APP13007, 0.1%
- Where
- 9 sites in United States
- Volunteers
- 165 people
- Sponsor
- Formosa Pharmaceuticals, Inc.
Moderate to Severe Plaque-type Psoriasis
First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks
The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
- Trial name
- FEATURE (NCT01555125)
- Testing
- secukinumab 150 mg, secukinumab 300 mg
- Where
- 33 sites in United States, Canada and 3 more
- Volunteers
- 177 people
- Sponsor
- Novartis Pharmaceuticals
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