Clinical trials: Pharmacodynamics
Heart Failure
A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction Between Aliskiren and Furosemide in Patients With Heart Failure
This study assessed the interaction between single and multiple doses of aliskiren (150 mg and 300 mg) and furosemide (60 mg) in patients with heart failure.
- Trial name
- NCT01125514
- Testing
- Aliskiren 150 mg, Furosemide 60 mg, Aliskiren 300 mg
- Where
- 2 sites in Germany, Lithuania
- Volunteers
- 37 people
- Sponsor
- Novartis Pharmaceuticals
Solid Tumors
A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.
This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.
- Trial name
- NCT04642365
- Testing
- RO7296682, Atezolizumab
- Where
- 10 sites in United States, Australia and 4 more
- Volunteers
- 49 people
- Sponsor
- Hoffmann-La Roche
Smoking
Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L
The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, and the safety and tolerability of the nicotine-containing aerosol delivered by Platform 3 Liquid…
- Trial name
- NCT02532374
- Testing
- Nicorette® inhalator, P3L
- Where
- New Zealand
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Beta Thalassemia Intermedia
Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx)
The purpose was to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of sapablursen administered subcutaneously to participants with non-transfusion dependent β-Thalassemia Intermedia.
- Trial name
- NCT04059406
- Testing
- sapablursen
- Where
- 19 sites in Australia, Greece and 3 more
- Volunteers
- 29 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Diabetes Mellitus, Type 1
Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days
Placebo-controlled, double blind (triple-dummy technique), randomised parallel design comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with T1DM as adjunctive therapy to insulin over 28 days.
- Trial name
- NCT01969747
- Testing
- Empagliflozin medium, Empagliflozin low
- Where
- 2 sites in Austria, Germany
- Volunteers
- 75 people
- Sponsor
- Boehringer Ingelheim
Sickle Cell Disease (SCD)
Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)
The purpose of the CSEG101A2202 study was to characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of SEG101/crizanlizumab and to evaluate the safety and efficacy of SEG101/crizanlizumab in sickle cell disease (SCD)…
- Trial name
- NCT03264989
- Testing
- crizanlizumab
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
Alzheimer Disease
Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab
This study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US).
- Trial name
- NCT00916617
- Testing
- bapineuzumab
- Where
- 16 sites in United States
- Volunteers
- 62 people
- Sponsor
- Pfizer
Type 1 Diabetes Mellitus
The PK and PD of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
This randomized, single-blind, 3 arm, parallel group, placebo controlled PK/PD study will enrol 30 Japanese male and female patients with T1DM and age 18 to 65 years, with inadequate glycemic control on insulin defined as HbA1c ≥…
- Trial name
- NCT02582840
- Testing
- Dapagliflozin 5mg, Dapagliflozin 10mg
- Where
- Japan
- Volunteers
- 42 people
- Sponsor
- AstraZeneca
Muscular Atrophy, Spinal
Investigate Safety, Tolerability, PK, PD and Efficacy of Risdiplam (RO7034067) in Infants With Type1 Spinal Muscular Atrophy
Open-label, multi-center clinical study is to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and efficacy of Risdiplam (RO7034067) in infants with Type 1 spinal muscular atrophy (SMA).
- Trial name
- FIREFISH (NCT02913482)
- Testing
- Risdiplam
- Where
- 32 sites in United States, Belgium and 14 more
- Volunteers
- 62 people
- Sponsor
- Hoffmann-La Roche
Kidney Transplantation
A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).
This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the…
- Trial name
- NCT01292226
- Testing
- mycophenolate mofetil, antibody induction, Cyclosporine
- Where
- 7 sites in Italy
- Volunteers
- 45 people
- Sponsor
- Hoffmann-La Roche
Healthy
A Study of LY2541546 in Healthy Postmenopausal Women
The purpose of this study is to determine if a single dose of LY2541546 has any side effects on the body and to determine how long and how much LY2541546 stays in the bloodstream of the body.
- Trial name
- NCT01742078
- Testing
- LY2541546 - IV, LY2541546 - SC
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants
The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of LY2963016 and two doses of US-approved Lantus®.
- Trial name
- NCT01688635
- Testing
- LY2963016, US Approved Lantus
- Where
- Singapore
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C
This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an…
- Trial name
- NCT03420768
- Testing
- BMS-986263
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Bristol-Myers Squibb
Healthy
A Study in Healthy Men to Test How Different Doses of BI 474121 Are Taken up and How They Influence the Amount of a Molecular Messenger (cGMP) in the Spinal Fluid
The main objectives of this trial are: To evaluate the effect of BI 474121 on cyclic guanosine monophosphate (cGMP) levels in cerebrospinal fluid (CSF) To assess the exposure of BI 474121 in CSF relative to plasma To determine…
- Trial name
- NCT04672954
- Testing
- 2.5 milligram (mg) BI 474121, 10 milligram (mg) BI 474121, 20 milligram (mg) BI 474121
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Heart Failure
Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide
Primary Trial objectives: To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in 50 healthy, male volunteers after single intravenous administration (8 subjects on verum per dose…
- Trial name
- COR-1-01 (NCT01043146)
- Testing
- COR-1
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Corimmun GmbH
Hypercholesterolemia
Phase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy
Evaluation of the clinical profile (lipid efficacy, safety and PK) across a number of doses of CIVI 007, a PCSK9 inhibitor. Patients to be evaluated will be on a stable background of statin therapy with or without ezetimibe.
- Trial name
- NCT04164888
- Testing
- CIVI 007
- Where
- 7 sites in United States
- Volunteers
- 49 people
- Sponsor
- Civi Biopharma, Inc.
Healthy Volunteers
A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, PD, safety and immunogenicity profile of MB09 with EU/US-Xgeva® in healthy male subjects.
- Trial name
- NCT05299073
- Testing
- MB09, US-sourced Xgeva, EU-sourced Xgeva
- Where
- Poland
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- mAbxience Research S.L.
Acromegaly
Assessment of BIM23B065, Given as Repeated Subcutaneous Injection in Subjects With Acromegaly
The purpose of the protocol is evaluate the safety, the pharmacodynamics and the pharmacokinetic of repeated administration of BIM23B065 in subjects with acromegaly.
- Trial name
- DOPAACRO 002 (NCT03045302)
- Testing
- BIM23B065
- Where
- 6 sites in Belgium, Hungary and 2 more
- Volunteers
- 4 people
- Sponsor
- Ipsen
Hepatitis C
Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone
Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to…
- Trial name
- NCT01637922
- Testing
- BI 201335
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Boehringer Ingelheim
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease
The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Secondary Hyperparathyroidism
- Trial name
- NCT01290029
- Testing
- Cinacalcet
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 14 people
- Sponsor
- Amgen
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