Clinical trials: Drug Dose
HIV Infections
Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected Thai Children
The purpose of this study is to compare the blood levels, absorption, and breakdown of lamivudine (3TC), nevirapine (NVP), and stavudine (d4T) in a fixed-dose tablet to that of the individual liquid formulations of the same…
- Trial name
- NCT00312091
- Testing
- Lamivudine, nevirapine, and stavudine fixed-dose tablet, Lamivudine, Nevirapine
- Where
- 4 sites in Thailand
- Volunteers
- 44 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory
First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological…
- Conditions
- Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory, Myelodysplastic Syndromes, Blastic Plasmacytoid Dendritic Cell Neoplasia
- Trial name
- NCT05086315
- Testing
- SAR443579
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 101 people
- Sponsor
- Sanofi
HIV Infections
A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients
The purpose of this study is to determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood).
- Trial name
- NCT00002406
- Testing
- Indinavir sulfate
- Where
- 29 sites in United States
- Volunteers
- 350 people
- Sponsor
- Merck Sharp & Dohme LLC
Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors
Pharmacokinetics, Safety, and Efficacy of Brigatinib Monotherapy in Pediatric and Young Adult Participants With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors
The purpose of this study is to estimate the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) regimen and characterize the pharmacokinetics (PK) of brigatinib monotherapy (film-coated tablets and age-appropriate…
- Conditions
- Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors, Solid Tumors
- Trial name
- NCT04260009
- Testing
- Brigatinib, Brigatinib AAF
- Sponsor
- Takeda
Pneumonia, Pneumocystis Carinii, HIV Infections
Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and children; to study the pharmacokinetics of orally administered dapsone in HIV-infected infants and children.
- Trial name
- NCT00000739
- Testing
- Dapsone
- Where
- 46 sites in United States, Puerto Rico
- Volunteers
- 96 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Spinal Muscular Atrophy Type 3
Evaluation of Safety and Efficacy of Gene Therapy Drug in the Treatment of Spinal Muscular Atrophy (SMA) Type 3 Patients
The study will evaluate safety and efficacy of intrathecal delivery of GC101 gene therapy drug as a treatment of spinal muscular atrophy Type 3 (SMA 3) patients.
- Trial name
- NCT06421831
- Testing
- GC101
- Where
- China
- Volunteers
- 21 people
- Sponsor
- GeneCradle Inc
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Heart Failure
Electronic Transmission of Laboratory and Adherence Records of Heart Failure Patients to General Practitioners Screen
Patients with heart failure (HF) need multiple guideline-directed medications to control the systolic and/or diastolic ventricular dysfunction.
- Trial name
- LabAdhDoc (NCT04326101)
- Testing
- Transmission of adherence records
- Where
- Switzerland
- Volunteers
- 9 people
- Sponsor
- University Hospital, Basel, Switzerland
B-cell Acute Lymphoblastic Leukemia (B-ALL)
Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).
- Trial name
- ALLight (NCT07109219)
- Testing
- AZD4512 monotherapy
- Where
- 27 sites in United States, Australia and 7 more
- Volunteers
- 83 people
- Sponsor
- AstraZeneca
Heart Failure
Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison
The overall objective of the proposed pilot study is to begin evaluation of two methods for promoting adherence to guidelines for beta-blocker therapy in heart failure.
- Trial name
- NCT01002456
- Testing
- Level 1: (provide site-specifi information), Level 2 (Provide site- and patient-specific information)
- Where
- United States
- Volunteers
- 220 people
- Sponsor
- US Department of Veterans Affairs
HIV Infections
The Safety and Effectiveness of HBY 097 Used With or Without AZT in HIV-Infected Patients Who Have Mild or No Symptoms
To obtain preliminary information on the safety, tolerability, and antiretroviral activity of HBY 097 alone or in combination with zidovudine ( AZT ) versus AZT alone. PER 1/19/96 AMENDMENT: AZT monotherapy arm was eliminated.
- Trial name
- NCT00002357
- Testing
- HBY 097, Zidovudine
- Where
- 6 sites in United States
- Volunteers
- 144 people
- Sponsor
- Hoechst Marion Roussel
Non-alcoholic Steatohepatitis
Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)
This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH).
- Trial name
- NCT05016882
- Testing
- NNC0194 0499 50 mg/mL, Semaglutide 3 mg/mL, NNC0174 0833 10 mg/mL
- Where
- 255 sites in United States, Australia and 22 more
- Volunteers
- 698 people
- Sponsor
- Novo Nordisk A/S
Migraine Disorders
A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses.
This is a pharmacokinetic (PK) study designed to investigate a combination product containing sumatriptan succinate and naproxen sodium administered at 3 single doses (10mg sumatriptan/60mg naproxen sodium, 30mg sumatriptan/180mg…
- Trial name
- NCT00989625
- Testing
- This is a pharmacokinetic study (Treximet)
- Where
- 3 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neonatal Abstinence Syndrome, Neonatal Opiate Withdrawal Syndrome
Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure
Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine.
- Trial name
- B-PHORE (NCT03608696)
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Thomas Jefferson University
HIV Infections
The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children
To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in combination with nelfinavir and nucleoside…
- Trial name
- NCT00002380
- Testing
- Nelfinavir mesylate, Saquinavir
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Hoffmann-La Roche
Schizophrenia
A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo.
- Trial name
- NCT04072354
- Testing
- SEP-363856 50mg, SEP-363856 75mg
- Where
- 53 sites in United States, Bulgaria and 4 more
- Volunteers
- 463 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Acute Lymphoblastic Leukemia (ALL)
Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL
Early intervention in children and adolescents who experience delayed MTX-clearance and renal dysfunction in ALL treatments with the enzyme Glucarpidase which rapidly hydrolyses MTX to non-toxic metabolites to avoid life…
- Trial name
- NOPHOCPG2 (NCT01305655)
- Testing
- Glucarpidase
- Where
- 5 sites in Denmark, Finland and 3 more
- Volunteers
- 47 people
- Sponsor
- Nordic Society for Pediatric Hematology and Oncology
HIV Infections
The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs
To evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule formulation (SQV-SGC) in combination with other antiretroviral drugs.
- Trial name
- NCT00002425
- Testing
- Saquinavir
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Hoffmann-La Roche
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
Elevated Lipoprotein(a), Cardiovascular Diseases
Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Warfarin
This is a single center, open label, single sequence, two-treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of a single dose of warfarin.
- Trial name
- NCT03426033
- Testing
- ISIS 681257, Warfarin
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Akcea Therapeutics