Clinical trials: Pharmacodynamics
Respiratory Depression
ENA-001 for Opioid Induced Respiratory Depression
This study is a Phase I clinical trial to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) profiles with single intravenous (IV) and intramuscular (IM) doses of ENA-001.
- Trial name
- NCT06967259
- Testing
- ENA-001
- Where
- 2 sites in United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Enalare Therapeutics Inc.
Rheumatoid Arthritis
A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA)
This single arm study will investigate the pattern of B cell depletion in synovial tissue and peripheral blood of patients with active RA, after MabThera (1000mg iv x 2 on days 1 and 15) + methotrexate (10-25mg/week po)…
- Trial name
- NCT00422942
- Testing
- rituximab [MabThera/Rituxan], Methotrexate
- Where
- Netherlands
- Volunteers
- 3 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers, Alzheimer Disease
A Study of LY4405094 in Healthy Participants and Participants With Alzheimer's Disease
The purpose of this study is to see how safe LY4405094 is and to see how much and how quickly LY4405094 gets into the bloodstream.
- Conditions
- Healthy Volunteers, Alzheimer Disease, Amyloid, Plaque, Amyloid
- Trial name
- NCT07787182
- Testing
- LY4405094, Florbetapir F18, Florbetaben F 18
- Where
- 18 sites in United States, China and 1 more
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Diabetes Mellitus
Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin
Primary Objective: To evaluate the effects of rifampicin on the pharmacokinetics (PK) of sotagliflozin and its metabolite in healthy male and female subjects.
- Trial name
- NCT03063580
- Testing
- Sotagliflozin (SAR439954), Rifampicin
- Where
- France
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy
A Study of HW243040 in Healthy Participants
This is a randomised, double-blind, placebo-controlled clinical trial intended to evaluate the safety, tolerability and pharmacokinetic profiles of HW243040 following single and multiple administrations in healthy study…
- Trial name
- NCT07737496
- Testing
- HW243040
- Where
- China
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Cystic Fibrosis
Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to…
- Trial name
- NCT00503490
- Testing
- MP-376 (Levofloxacin solution for Inhalation)
- Where
- 14 sites in United States
- Volunteers
- 40 people
- Sponsor
- Amgen
Huntington Disease
Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease
WVE-HDSNP2-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120102 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism…
- Trial name
- NCT04617860
- Testing
- WVE-120102
- Where
- 20 sites in Australia, Canada and 5 more
- Volunteers
- 36 people
- Sponsor
- Wave Life Sciences USA, Inc.
Prostate Cancer
Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2032 versus Eligard, in patients with prostate cancer.
- Trial name
- NCT02212197
- Testing
- leuprolide acetate FluidCrystal® injection depot, leuprolide acetate
- Where
- 7 sites in Finland, Hungary
- Volunteers
- 51 people
- Sponsor
- Camurus AB
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers
The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-104 when given to healthy male volunteers.
- Trial name
- NOCIFIM (NCT01840423)
- Testing
- ODM-104, Entacapone, levodopa/carbidopa
- Where
- Germany
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Orion Corporation, Orion Pharma
Healthy
JNJ-41443532 Sex, Race, and Age Pharmacokinetic (PK) Study
The purpose of this study is to assess the safety, tolerability pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and how it is removed from the body over time) and pharmacodynamics…
- Trial name
- NCT01105780
- Testing
- JNJ-41443532
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
A Study of LY3819469 in Healthy Participants
This is a 2-part study. In Part A, the main purpose is to evaluate the safety and tolerability of the study drug LY3819469 in healthy participants with high lipoprotein (a) [Lp(a)] levels.
- Trial name
- NCT04914546
- Testing
- LY3819469
- Where
- 5 sites in United States, Singapore
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Solid Tumors, Lymphoma, Non-Hodgkin
Phase 1 Every-3-Week Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04630)
Part 1 and Part 2 of this trial will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered every 3 weeks as a 2 hour intravenous (IV) infusion (Part 1), and as an…
- Conditions
- Solid Tumors, Lymphoma, Non-Hodgkin, Multiple Myeloma
- Trial name
- NCT00871910
- Testing
- SCH 727965, Aprepitant, Ondansetron
- Volunteers
- 81 people
- Sponsor
- Merck Sharp & Dohme LLC
Psoriasis
Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis
The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis
- Trial name
- NCT00563524
- Testing
- ILV-094
- Where
- 24 sites in United States, Canada and 2 more
- Volunteers
- 76 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL
The purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-2575 single agent and in combination with other therapeutic agents in patients with relapsed/refractory CLL/SLL.
- Trial name
- NCT04494503
- Testing
- APG-2575, Rituximab, Ibrutinib
- Where
- 18 sites in China
- Volunteers
- 123 people
- Sponsor
- Ascentage Pharma Group Inc.
Healthy
Safety, Pharmacodynamic and Pharmacokinetic Effects of QAX576 in Healthy Volunteers.
This study is designed to evaluate the safety, pharmacodynamic and pharmacokinetic effects of individual escalating intravenous doses of QAX576 in healthy volunteers.
- Trial name
- NCT00417196
- Testing
- QAX576
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis
Cerebral Amyloid Angiopathy
A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy
The purpose of the study is to evaluate the effect of ALN-APP on measures of CAA disease progression and to characterize the safety, tolerability, and pharmacodynamics (PD) of ALN-APP in adult patients with sporadic CAA (sCAA)…
- Trial name
- cAPPricorn-1 (NCT06393712)
- Testing
- ALN-APP
- Where
- 57 sites in United States, Australia and 4 more
- Volunteers
- 210 people
- Sponsor
- Alnylam Pharmaceuticals
Diabetes Mellitus
Single Ascending Dose Trial in Patients With Type 2 Diabetes
The purpose of this study is to determine whether AMG 876 is safe and well tolerated in subjects with type 2 diabetes.
- Trial name
- NCT01492465
- Testing
- AMG 876
- Where
- 3 sites in United States
- Volunteers
- 47 people
- Sponsor
- Amgen
Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
The objective of this study is to evaluate the safety, tolerability, efficacy profile, and effect on growth and development of vorasidenib in pediatric participants aged 12 to < 18 years old with grade 2 glioma with an IDH1 or…
- Trial name
- NCT07286292
- Testing
- Vorasidenib
- Where
- 5 sites in United States, Australia
- Volunteers
- 10 people
- Sponsor
- Institut de Recherches Internationales Servier (I.R.I.S.)
Healthy Adults
Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy adult subjects.
- Trial name
- NCT02145234
- Testing
- BMS-986089
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Chronic Obstructive Pulmonary Disease (COPD)
Safety and Tolerability of Multiple Inhaled NVA237 Doses in Chronic Obstructive Pulmonary Disease (COPD) Patients
This study will evaluate the pharmacokinetics, pharmacodynamics and safety of multiple doses of the NVA237 in mild and moderate COPD patients .
- Trial name
- NCT00545311
- Testing
- NVA237
- Where
- 4 sites in Denmark, Germany
- Volunteers
- 40 people
- Sponsor
- Novartis
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