Clinical trials: Safety and Tolerability
Rheumatoid Arthritis (RA)
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) compared with adalimumab.
- Trial name
- NCT03823391
- Testing
- ABBV-3373, Adalimumab
- Where
- 30 sites in United States, Germany and 5 more
- Volunteers
- 48 people
- Sponsor
- AbbVie
Hepatic Impairment
Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
The study is to estimate the effect of hepatic impairment on the plasma PK of PF-07321332/ritonavir. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted…
- Trial name
- NCT05005312
- Testing
- PF-07321332, Ritonavir
- Where
- 2 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Pfizer
Portal Hypertension
A Study to Investigate the Safety and Effect of the Study Drug (FE 204205) in Patients With Cirrhotic Portal Hypertension
The purpose of this trial is to investigate safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) after intravenous (IV) administration of FE 204205 in patients with cirrhotic portal hypertension.
- Trial name
- NCT02929407
- Testing
- FE 204205
- Where
- Spain
- Volunteers
- 4 people
- Sponsor
- Ferring Pharmaceuticals
Primary Haemophagocytic Lymphohistiocytosis
Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With Primary Haemophagocytic Lymphohistiocytosis
The purpose of this study is to assess the safety, tolerability and efficacy of a new drug aimed at controlling disease activity in patients diagnosed with primary haemophagocytic lymphohistiocytosis.
- Trial name
- NCT01818492
- Testing
- NI-0501
- Where
- 20 sites in United States, Germany and 4 more
- Volunteers
- 45 people
- Sponsor
- Swedish Orphan Biovitrum
Kidney Transplantation
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based…
- Trial name
- NCT00282568
- Testing
- Tacrolimus Modified Release (MR), tacrolimus
- Where
- 9 sites in United States, Canada
- Volunteers
- 70 people
- Sponsor
- Astellas Pharma Inc
Healthy
Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years
The purpose of this study is to assess the safety of Takeda's tetravalent dengue vaccine (TDV) (previously DENVax) administered subcutaneously in healthy adults and children.
- Trial name
- NCT01511250
- Testing
- TDV
- Where
- 8 sites in Colombia, Puerto Rico and 2 more
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Takeda
Sickle Cell Anemia
Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia
The study assesses the efficacy, safety and tolerability of ACZ885 (canakinumab) in pediatric and young adult patients with sickle cell anemia (SCA).
- Trial name
- NCT02961218
- Testing
- ACZ885
- Where
- 15 sites in United States, Canada and 5 more
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
Infection, Human Immunodeficiency Virus
Phase IIa Dose-ranging Study of GSK1349572 in HIV-1 Infected Adults
GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase IIa, multicenter, randomized, parallel, double-blind, dose ranging, placebo-controlled 'proof of concept' study is to be…
- Trial name
- NCT00708110
- Testing
- GSK1349572
- Where
- 18 sites in United States
- Volunteers
- 35 people
- Sponsor
- ViiV Healthcare
Smallpox
Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.
- Trial name
- NCT00053482
- Testing
- ACAM2000 Smallpox Vaccine, Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®
- Where
- 3 sites in United States
- Volunteers
- 357 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Cancer, Tumors
A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors
The purpose of this study is to investigate BMS-986226 administered alone or in combination with nivolumab or ipilimumab.
- Conditions
- Cancer, Tumors, Neoplasm, Malignancy
- Trial name
- NCT03251924
- Testing
- BMS-986226, Nivolumab, Ipilimumab
- Where
- 13 sites in United States, Canada and 2 more
- Volunteers
- 80 people
- Sponsor
- Bristol-Myers Squibb
Prurigo Nodularis, Pruritis
Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis
Study of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of Vixarelimab (KPL-716) in subjects with prurigo nodularis (PN).
- Trial name
- NCT03816891
- Testing
- Vixarelimab
- Where
- 86 sites in United States, Australia and 11 more
- Volunteers
- 240 people
- Sponsor
- Genentech, Inc.
Obesity
To Investigate the Safety, Tolerability and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes
This study is the first administration of GSK2890457 in humans. The study will be conducted in 3 parts: - Part A (conducted at a single investigative site) will determine the safety and tolerability of GSK2890457 alone in healthy…
- Trial name
- NCT01725126
- Testing
- GSK2890457, Metformin, Liraglutide
- Where
- 3 sites in United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cytomegalovirus Infections
Safety and Immunogenicity of the Human Cytomegalovirus (CMV) Vaccine (V160) in Healthy Japanese Men (V160-003)
The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160 administered by intramuscular (IM) injection in healthy Japanese male participants by cytomegalovirus (CMV) serostatus.
- Trial name
- NCT03840174
- Testing
- V160
- Where
- Japan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
AL Amyloidosis
Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
The rationale for this study is to provide additional treatment with NEOD001 for subjects who complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability.
- Trial name
- OLE (NCT02613182)
- Testing
- NEOD001
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Prothena Biosciences Ltd.
Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma
Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma
Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma.
- Trial name
- NCT01661179
- Testing
- Vandetanib 300mg
- Where
- 4 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Genzyme, a Sanofi Company
Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial
Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)
The purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children.
- Conditions
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria
- Trial name
- NCT00761527
- Testing
- Desloratadine Syrup
- Volunteers
- 2,980 people
- Sponsor
- Organon and Co
DM1, Myotonic Dystrophy 1
Study of AOC 1001 in Adult Myotonic Dystrophy Type 1 (DM1) Patients
AOC 1001-CS1 is a randomized, double-blind, placebo-controlled, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple-doses of AOC 1001 Administered Intravenously to…
- Conditions
- DM1, Myotonic Dystrophy 1, Myotonic Dystrophy, Myotonic Dystrophy Type 1 (DM1)
- Trial name
- MARINA (NCT05027269)
- Testing
- AOC 1001
- Where
- 8 sites in United States
- Volunteers
- 39 people
- Sponsor
- Avidity Biosciences, Inc.
Diabetes Mellitus, Type 2
Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Empagliflozin in Chinese Female and Male Patients With Type 2 Diabetes Mellitus
the pharmacokinetics, pharmacodynamics and safety and tolerability of single and multiple oral doses of BI 10773 at low dose once daily (q.d.) and high dose q.d.
- Trial name
- NCT01316341
- Testing
- BI10773
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Boehringer Ingelheim
Diabetic Retinopathy
HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia
This is a study in people with a type of diabetic eye disease called diabetic retinopathy with diabetic macular ischemia. People who have had laser treatment for their diabetic retinopathy can participate in the study.
- Trial name
- HORNBILL (NCT04424290)
- Testing
- BI 764524
- Where
- 19 sites in United States, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Boehringer Ingelheim
Alzheimer's Disease
A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type…
- Trial name
- NCT03594123
- Testing
- Brexpiprazole
- Where
- United States
- Volunteers
- 259 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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