Clinical trials: Drug Safety
Drug Safety
Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy Subjects
This is a single-center, randomized, double-blind, placebo-controlled, ascending single-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects.
- Trial name
- NCT01367873
- Testing
- VIA-3196
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Coronary Artery Disease
SELUTION 4 De Novo Small Vessel IDE Trial
Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as…
- Trial name
- NCT05946629
- Testing
- PCI with SELUTION SLR DCB, PCI with FDA approved "-limus" DES
- Where
- 70 sites in United States, Belgium and 1 more
- Volunteers
- 960 people
- Sponsor
- M.A. Med Alliance S.A.
Parkinson Disease, Dyskinesia, Drug-Induced
Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced…
- Conditions
- Parkinson Disease, Dyskinesia, Drug-Induced, Levodopa
- Trial name
- NCT01173731
- Testing
- AFQ056
- Where
- 22 sites in United States, Australia and 4 more
- Volunteers
- 66 people
- Sponsor
- Novartis Pharmaceuticals
Pain, Postoperative
A Comparison of the Safety and Effectiveness of Two Forms of Patient-controlled Pain Medication Used After Scheduled Abdominal or Pelvic Surgery: The Fentanyl Transdermal System Versus the Morphine Intravenous Pump
The purpose of this study is to compare two pain medications delivered by two different forms of patient-controlled pain management systems: the Fentanyl HCl Patient-Controlled Transdermal System (E-TRANS fentanyl) and the…
- Trial name
- NCT00266539
- Testing
- E-TRANS Fentanyl hydrochloride; Morphine
- Volunteers
- 506 people
- Sponsor
- Alza Corporation, DE, USA
Dyslipidemias, Cardiovascular Diseases
A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
Atherogenic dyslipidemia includes patients who have coronary heart disease (CHD) or CHD risk equivalents, whose TG level is not adequately controlled after statin monotherapy.
- Conditions
- Dyslipidemias, Cardiovascular Diseases, Hypertriglyceridemia
- Trial name
- NCT01462877
- Testing
- fenofibrate
- Where
- China
- Volunteers
- 506 people
- Sponsor
- Abbott
Burkitt Lymphoma, Precursor B-cell Lymphoblastic Leukemia-Lymphoma
A Safety Study of SGN-CD19A for Leukemia and Lymphoma
This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL)…
- Trial name
- NCT01786096
- Testing
- SGN-CD19A
- Where
- 13 sites in United States
- Volunteers
- 92 people
- Sponsor
- Seagen Inc.
Advanced Hepatocellular Carcinoma
A Phase I, Open Label, Non Randomized, Multicenter, Dose Escalation Clinical Study to Investigate Safety and Tolerability of OPB(Otsuka Pharmaceutical Biwa)-111077 in Subjects With Advanced HCC(Hepatocellular Carcinoma)
This is a Phase I, open label, non randomized, multicenter study designed to investigate the safety and tolerability of escalating doses of OPB-111077 administered orally, once daily in subjects with advanced HCC.
- Trial name
- NCT01942083
- Testing
- OPB-111077
- Where
- South Korea
- Volunteers
- 33 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Encephalitis, Encephalitis, Viral
Venezuelan Equine Encephalitis Monovalent Virus-Like Particle Vaccine
The primary objective of the study is to evaluate the safety and immunogenicity of non-adjuvanted and adjuvanted monovalent VEE VLP Vaccine in healthy adults (ages 18-50 years) when administered via intramuscular (IM) injection…
- Conditions
- Encephalitis, Encephalitis, Viral, Infectious Encephalitis, Virus Diseases
- Trial name
- VEEV (NCT03776994)
- Testing
- Vaccinations on Day 0, Day 28, and Day 140
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- SRI International
Ototoxicity
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing…
- Trial name
- NCT02819856
- Testing
- SPI-1005 Ebselen 200mg Capsule x1, SPI-1005 Ebselen 200mg Capsule x2, SPI-1005 Ebselen 200mg Capsule x3
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Diabetes Mellitus, Type 2, Obesity
A Research Study of the New Medicine NNC0519-0130 in Male Chinese Participants Living With Excess Body Weight
Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and excess body weight.
- Trial name
- NCT07004322
- Testing
- NNC0519-0130
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Novo Nordisk A/S
Solid Tumor
PF-07284892 in Participants With Advanced Solid Tumors
The purpose of this first-in-patient, open label study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and…
- Trial name
- NCT04800822
- Testing
- PF-07284892, lorlatinib, binimetinib
- Where
- 11 sites in United States
- Volunteers
- 53 people
- Sponsor
- Pfizer
Alcohol Dependence
Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients with Alcohol Dependence
The purpose of this study is to investigate the safety and the prognosis after achieving reduced alcohol intake in patients with alcohol dependence who received treatment for the reduction of alcohol intake in the routine…
- Trial name
- NCT04107051
- Testing
- Nalmefene Hydrochloride Hydrate
- Where
- Japan
- Volunteers
- 533 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Epilepsy
Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release…
- Trial name
- NCT00175903
- Testing
- Levetiracetam, Carbamazepine Controlled Release (CBZ-CR), Valproate Extended Release
- Where
- 229 sites in Australia, Austria and 22 more
- Volunteers
- 1,701 people
- Sponsor
- UCB Pharma
Sleep Initiation and Maintenance Disorders
Efficacy of Ramelteon in Subjects With Chronic Insomnia
The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD), in subjects with chronic insomnia.
- Trial name
- NCT00671086
- Testing
- Ramelteon
- Where
- 122 sites in United States
- Volunteers
- 1,213 people
- Sponsor
- Takeda
Allergic Asthma, Uncontrolled Moderate to Severe
Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma
The purpose of this study is to evaluate the efficacy and safety of Omalizumab produced by CinnaGen compared with Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp, Switzerland) in subjects with uncontrolled…
- Trial name
- NCT05813470
- Testing
- Omalizumab (CinnaGen), Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)
- Where
- 22 sites in Iran
- Volunteers
- 256 people
- Sponsor
- Cinnagen
Type 2 Diabetes Mellitus
An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)
A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin.
- Trial name
- NCT00511472
- Testing
- MK-0941, LANTUS insulin
- Volunteers
- 70 people
- Sponsor
- Merck Sharp & Dohme LLC
Diabetes Mellitus, Type 2
Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus
This is a phase III, randomized, double-blind, multicenter, parallel group, repeat-dose, study of 26 weeks duration to evaluate the efficacy, safety, tolerability and pharmacodynamic response of albiglutide liquid drug product…
- Trial name
- NCT02683746
- Testing
- Lyophilized albiglutide DCC pen injector, Albiglutide liquid auto-injector
- Where
- 70 sites in United States
- Volunteers
- 308 people
- Sponsor
- GlaxoSmithKline
Rheumatoid Arthritis
Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis
This study will assess the safety and pharmacokinetic comparability of two VAY736 drug products in patients with rheumatoid arthritis.
- Trial name
- NCT03574545
- Testing
- ianalumab
- Where
- 2 sites in Germany, Jordan
- Volunteers
- 48 people
- Sponsor
- Novartis Pharmaceuticals
Thrombosis
Study Investigation Pharmacokinetics and Pharmacodynamics of CS1
SAD study: Eighteen subjects will be included in the SAD study (single dose) in 3 parallel arms, each with 6 subjects. The 3 arms will receive a single dose of one of the CS1 formulations I, II or III.
- Trial name
- NCT03903302
- Testing
- CS1-Sodium Valproate
- Where
- Sweden
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cereno Scientific AB
Chronic Pain
A Study to Assess the Safety and Effectiveness of Durogesic (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Long-term Narcotic Pain Relief Therapy
The purpose of this study is to assess the effectiveness and safety of Durogesic® (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the treatment of children with chronic pain requiring long-term narcotic…
- Trial name
- NCT00271453
- Testing
- Durogesic® (fentanyl transdermal drug delivery system)
- Volunteers
- 41 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.