Clinical trials: Single Dose
Influenza, Human, Arthralgia
An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection
Influenza infection is an important public health priority, with seasonal outbreaks and pandemics causing considerable global morbidity and mortality.
- Trial name
- NCT04494412
- Testing
- Zanamivir
- Where
- 6 sites in Italy, Poland and 1 more
- Volunteers
- 8 people
- Sponsor
- GlaxoSmithKline
Neoplasms, Brain
A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects
This was a 2-part, Phase I/IIa, multi-center, open label, study in pediatric and adolescent patients with advanced BRAF V600 mutation-positive solid tumors.
- Trial name
- NCT01677741
- Testing
- Dabrafenib
- Where
- 26 sites in United States, Australia and 8 more
- Volunteers
- 85 people
- Sponsor
- Novartis Pharmaceuticals
Infections, Meningococcal
Assess the Non-inferiority of GSK Biologicals' Mencevax™ ACWY (Manufactured by a New Process) vs Mencevax™ ACWY (the Already Existing Vaccine in the Market) When Given as a Single Dose to Subjects Aged 2-30 Yrs
The purpose of this study is to evaluate that the vaccine produced with the new process and administered as a single dose is at least as good as the existing Mencevax™ ACWY vaccine in terms of immunogenicity, safety and…
- Trial name
- NCT00227422
- Testing
- Mencevax ACWY
- Where
- Lebanon
- Volunteers
- 324 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pertussis
3-year Follow-up After a Single Dose Acellular Pertussis Vaccination
In July 2015-November 2016, a phase II/III randomized, observer-blind,controlled study of two acellular Pertussis vaccines (aP standalone and TdaP combined vaccined) manufactured by BioNet-Asia Co., Ltd.
- Trial name
- NCT04102137
- Testing
- Pertagen (aP BioNet), Boostagen (TDaP BioNet), Adacel
- Where
- Thailand
- Volunteers
- 181 people, healthy volunteers welcome
- Sponsor
- Mahidol University
Polycystic Kidney, Autosomal Recessive
A Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
This study evaluates safety and tolerability of a single ascending dose of a tesevatinib liquid formulation administered to pediatric subjects with ARPKD.
- Trial name
- NCT03096080
- Testing
- Tesevatinib
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Kadmon Corporation, LLC
Precursor B-Cell Acute Lymphoblastic Leukemia
Blinatumomab Plus Reduced-dose Chemotherapy in Treating B-ALL
Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults.
- Trial name
- NCT06742515
- Testing
- Blinatumomab plus Reduced-dose Chemotherapy
- Where
- China
- Volunteers
- 20 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Kidney Transplant
Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients
The purpose of this study is to evaluate how well adolescent kidney transplant patients tolerate a single dose of belatacept they receive at least 6 months after transplant surgery, and how their body handles the drug.
- Trial name
- NCT01791491
- Testing
- Belatacept
- Where
- 8 sites in United States
- Volunteers
- 16 people
- Sponsor
- Bristol-Myers Squibb
Kidney Disease, Chronic, Transplant Recipient (Kidney)
Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus
This is a phase IV multicentre adaptive single-blinded randomized clinical trial to evaluate if preemptively genotyping populations at pretransplant chronic kidney disease susceptible of receiving tacrolimus therapy is effective…
- Conditions
- Kidney Disease, Chronic, Transplant Recipient (Kidney), Immunosuppression
- Trial name
- TRANSPGx (NCT06701825)
- Testing
- Tacrolimus
- Where
- Spain
- Volunteers
- 114 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
Genetic Disease, Nonsense Mutation
A Phase 2 Study of ELX-02 in Patients With Nephropathic Cystinosis
This is a Phase 2 open label study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 in patients with cystinosis with nonsense mutation in at least one allele.
- Conditions
- Genetic Disease, Nonsense Mutation, Cystinosis
- Trial name
- NCT04069260
- Testing
- ELX-02
- Where
- Canada
- Volunteers
- 3 people
- Sponsor
- Eloxx Pharmaceuticals, Inc.
Stargardt Disease 1, STGD1
A Phase 1, First-in-Human Study of CITY-RBP4 in Healthy Volunteers and STGD1 Participants
This is a first-in-human (FIH), multicenter, randomized, double-masked, placebo-controlled adaptive clinical study evaluating the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of CITY-RBP4, following…
- Conditions
- Stargardt Disease 1, STGD1, Healthy Volunteers
- Trial name
- NCT07836452
- Testing
- CITY-RBP4
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- City Therapeutics
Influenza
Study of a Single Dose or Two Doses of a Quadrivalent Influenza Vaccine in Subjects Aged 6 Months or Older in India
The aim of the study was to generate immunogenicity and safety data in the whole population to support registration of the Quadrivalent Influenza Vaccine (QIV) in India: Primary objective: To describe in each age group the immune…
- Trial name
- NCT02451358
- Testing
- Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative, Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative, Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative
- Where
- 8 sites in India
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pain
Comparison of Low-dose Epidural With Intravenous Narcotic Versus Intravenous Narcotic Alone
The purpose of the study is to determine if a low-dose epidural drug mixture without narcotic will result in lower parenteral narcotic usage, and improved side-effect profile for post-operative pain in the pediatric population…
- Trial name
- NCT00287326
- Testing
- Bupivacaine, Clonidine, Morphine
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of North Carolina, Chapel Hill
Epilepsy
Valproate Dose Reduction and Its Clinical Evaluation by Introducing Lamotrigine in Japanese Women With Epilepsy - Single Arm, Multicenter, and Open-label Study
The purpose of this study is to examine whether the VPA (Valproate) dose can be reduced by additional administration of LTG (Lamotrigine) in Japanese pre-menopausal female epilepsy patients aged 15 years or older, whose seizures…
- Trial name
- NCT02100644
- Testing
- Lamotrigine tablets 25/100 mg
- Where
- 7 sites in Japan
- Volunteers
- 33 people
- Sponsor
- GlaxoSmithKline
RSV Illness in ≤12 Months of Participants
A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness
The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are…
- Trial name
- NCT00421304
- Testing
- Motavizumab
- Where
- 35 sites in United States, Australia and 3 more
- Volunteers
- 118 people
- Sponsor
- MedImmune LLC
Acute Lymphoblastic Leukemia
CAV Regimen for R/R Ph- B-ALL
This study aims to investigate the efficacy and safety of cladribine, venetoclax combined with cytarabine and venetoclax (CAV regimen) for relapsed/refractory (R/R) Philadelphia Chromosome-negative (Ph-) B-cell acute…
- Trial name
- NCT05657652
- Testing
- cladribine, cytarabine,venetoclax
- Where
- China
- Volunteers
- 36 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Healthy
Pharmacokinetics And Safety Study Of Two CP-690,550 Controlled Release Formulation Following Single Dose In Healthy Volunteers
This study will explore the drug behavior and safety following single dose of two 20 milligram CP-690,550 osmotic capsules in 12 healthy volunteers.
- Trial name
- NCT01185184
- Testing
- CP-690,550
- Where
- Singapore
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Post-operative Pain
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen Plus® and Panadeine® Extra.
- Trial name
- NCT01229449
- Testing
- Ibuprofen/acetaminophen, Ibuprofen/acetaminophen (higher dose), Nurofen Plus®
- Where
- United States
- Volunteers
- 678 people
- Sponsor
- Reckitt Benckiser LLC
Duchenne Muscular Dystrophy, Exon 44
Study of AOC 1044 in Healthy Adult Volunteers and Participants With Duchenne Muscular Dystrophy (DMD) Mutations Amenable to Exon 44 Skipping
AOC 1044-CS1 (EXPLORE44) is a Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of single and multiple ascending doses of AOC 1044 in healthy adult volunteers and participants…
- Trial name
- EXPLORE44 (NCT05670730)
- Testing
- AOC 1044
- Where
- 10 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Avidity Biosciences, Inc.
Epilepsy
A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy
The purpose of the study is to assess the pharmacokinetics (PK), tolerability, and safety of Staccato alprazolam in adolescent study participants with epilepsy following single-dose administration.
- Trial name
- NCT04857307
- Testing
- Alprazolam
- Where
- 8 sites in United States
- Volunteers
- 14 people
- Sponsor
- UCB Biopharma SRL
Drugs, Investigational
Evaluate Analgesic Efficacy of Fast Release Aspirin
The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of fast release aspirin tablets, 1000 mg (2 x 500 mg) compared to regular aspirin tablets, 1000 mg (2 x 500 mg) and placebo in subjects with…
- Trial name
- TAROT (NCT01117636)
- Testing
- Acetylsalicylic acid (Fast release Aspirin, BAY1019036), Acetylsalicylic Acid (Aspirin, BAYE4465)
- Where
- 2 sites in United States
- Volunteers
- 514 people
- Sponsor
- Bayer