Clinical trials: Drug Safety
Healthy Volunteers
A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
- Trial name
- NCT03948581
- Testing
- Vedolizumab SC
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Takeda
Glycemic Control
Comparison of Fasiglifam (TAK-875) to Placebo and Sitagliptin in Combination With Metformin in Participants With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy of 2 doses of TAK-875 (25 mg and 50 mg), once daily (QD), plus metformin compared to placebo plus metformin and sitagliptin plus metformin on lowering blood sugar.
- Trial name
- NCT01549964
- Testing
- Fasiglifam (TAK-875), Sitagliptin
- Where
- 160 sites in United States, Australia and 9 more
- Volunteers
- 916 people
- Sponsor
- Takeda
Seasonal Allergic Rhinitis
Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber
The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.
- Trial name
- NCT01222299
- Testing
- bepotastine besilate nasal product - low dose, bepotastine besilate nasal product - medium dose, bepotastine besilate nasal product - high dose
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- Bausch & Lomb Incorporated
Essential Hypertension
Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Moderate to Severe Hypertension.
The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil plus chlorthalidone, once daily (QD), to olmesartan medoxomil plus hydrochlorothiazide in participants with moderate to severe…
- Trial name
- NCT01033071
- Testing
- Azilsartan medoxomil and chlorthalidone, Olmesartan medoxomil and hydrochlorothiazide
- Where
- 94 sites in United States, Canada
- Volunteers
- 1,071 people
- Sponsor
- Takeda
Healthy, PK Drug-drug Interaction Study
Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension
This study has been designed to assess the safety, tolerability, and pharmacokinetics of a therapeutic dose of hydrocodone bitartrate with and without an oral dose of doxapram hydrochloride in healthy volunteers who are…
- Trial name
- NCT06585163
- Testing
- Hydrocodone Bitartrate, Hydrocodone Bitartrate + Doxapram Hydrochloride
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Quivive Pharma, Inc.
Knee Osteoarthritis
A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (OA)
The study was established to show safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).
- Trial name
- NCT04814368
- Testing
- canakinumab, LNA043
- Where
- 11 sites in United States, Czechia and 4 more
- Volunteers
- 23 people
- Sponsor
- Novartis Pharmaceuticals
COPD
A Study of RPL554 Drug Administered by Metered Dose Inhaler to Treat Chronic Obstructive Pulmonary Disease
The purpose of this study is to investigate 5 doses of RPL554 and placebo, administered by pressurized metered dose inhaler (pMDI), in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
- Trial name
- NCT04091360
- Testing
- Part A: RPL554, Part B: RPL554
- Where
- 2 sites in United Kingdom
- Volunteers
- 40 people
- Sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
Influenza, SARS-CoV-2
A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine)
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to <65…
- Trial name
- NCT06508320
- Testing
- mRNA-1083
- Where
- 17 sites in United States, Canada
- Volunteers
- 931 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
β-thalassemia Major
A Study Evaluating the Safety and Efficacy of the LentiGlobin BB305 Drug Product in β-Thalassemia Major Participants
This is a non-randomized, open label, multi-site, single-dose, phase 1/2 study in up to 18 participants (including at least 3 adolescents between 12 and 17 years of age, inclusive) with β-thalassemia major.
- Trial name
- NCT01745120
- Testing
- LentiGlobin BB305 Drug Product
- Where
- 6 sites in United States, Australia and 1 more
- Volunteers
- 19 people
- Sponsor
- Genetix Biotherapeutics Inc.
Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2)
A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy
The main aims of the study are: To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate. To check what dose range provides adequate relief of narcolepsy symptoms.
- Trial name
- NCT04096560
- Testing
- TAK-994
- Where
- 78 sites in United States, Canada and 10 more
- Volunteers
- 97 people
- Sponsor
- Takeda
Cachexia, Non-Small-Cell Lung Cancer
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.
- Conditions
- Cachexia, Non-Small-Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer
- Trial name
- NCT04299048
- Testing
- PF-06946860
- Where
- 10 sites in United States
- Volunteers
- 11 people
- Sponsor
- Pfizer
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
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
- NCT00372489
- Testing
- peginesatide
- Where
- 9 sites in United States
- Volunteers
- 81 people
- Sponsor
- Affymax
Chronic Obstructive Pulmonary Disease (COPD)
Study Comparing Dual Combination of Product (Budesonide and Formoterol) Given Via Two Different Inhalers. To See Which One Results in the Best Effect on Breathing.
Study comparing the same drugs as a dual combination product (budesonide and formoterol) given via two different inhalers. To see which one results in the best effect on breathing.
- Trial name
- NCT04078126
- Testing
- BFF, Symbicort Turbuhaler
- Where
- 4 sites in Germany
- Volunteers
- 35 people
- Sponsor
- AstraZeneca
Myelofibrosis With Myeloid Metaplasia, Myeloid Metaplasia
A Phase II Study of Pomalidomide in Myelofibrosis With Myeloid Metaplasia
The purpose of this study is to determine the safety of and to select a treatment regimen of pomalidomide (CC-4047) either as single-agent or in combination with prednisone to study further in patients with myelofibrosis with…
- Conditions
- Myelofibrosis With Myeloid Metaplasia, Myeloid Metaplasia, Myelofibrosis
- Trial name
- NCT00463385
- Testing
- Pomalidomide, Prednisone
- Where
- 11 sites in United States, Austria and 3 more
- Volunteers
- 88 people
- Sponsor
- Celgene
Degenerative Disc Disease
Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in…
- Trial name
- MSB-DR003 (NCT02412735)
- Testing
- Rexlemestrocel-L, Rexlemestrocel-L + HA Mixture
- Where
- 48 sites in United States, Australia
- Volunteers
- 404 people
- Sponsor
- Mesoblast, Ltd.
Mucopolysaccharidosis (MPS)
Safety, Tolerability, Ascending Dose and Dose Frequency Study of rhHNS Via an IDDD in MPS IIIA Patients
Sanfilippo syndrome, or Mucopolysaccharidosis (MPS) III, is a rare lysosomal storage disease (LSD) caused by loss in activity of 1 of 4 enzymes necessary for degradation of the glycosaminoglycan (GAG) heparan sulfate (HS) in…
- Trial name
- NCT01155778
- Testing
- Recombinant human heparan N-sulfatase (rhHNS)
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 12 people
- Sponsor
- Shire
Multiple Myeloma
ABC294640 (Opaganib) in Refractory / Relapsed Multiple Myeloma
This is a Phase Ib/II safety and efficacy trial of single agent ABC294640, an inhibitor of sphingosine kinase 2 and dihydroceramide desaturase, in refractory or relapsed multiple myeloma (MM).
- Trial name
- ABC-103 (NCT02757326)
- Testing
- Opaganib
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- RedHill Biopharma Limited
Leakage, Skin Condition
Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care
The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.
- Trial name
- NCT01517178
- Testing
- New ostomy base plate (SS), Standard Care base plate
- Where
- 11 sites in Denmark, France and 2 more
- Volunteers
- 33 people
- Sponsor
- Coloplast A/S
HIV Infections
Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents
First-line antiretroviral regimens are highly efficacious and generally well tolerated. However, as these regimens need to be taken life-long, there is growing concern about long-term toxicities associated with these regimens.
- Trial name
- NCT03682848
- Testing
- DTG + 3TC FDC
- Where
- 8 sites in Kenya, South Africa and 1 more
- Volunteers
- 32 people
- Sponsor
- ViiV Healthcare
Celiac Disease
A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in…
- Trial name
- NCT05353985
- Testing
- TAK-062, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar
- Where
- 102 sites in United States, Belgium and 6 more
- Volunteers
- 153 people
- Sponsor
- Takeda
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