Clinical trials: Pharmacodynamics
Healthy
Single Dose Study to Assess the Safety, Tolerability, Concentration in Body and Effect of BAF312
The purpose of this study is to assess the safety, tolerability, and effect of oral BAF312 on bodily functions as well as the body's absorption, distribution, metabolism, and excretion of BAF312 in healthy volunteers
- Trial name
- NCT00422175
- Testing
- BAF 312
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Novartis
Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
This is a study to evaluate how the body handles and metabolizes (PK) the various doses of the drug Tolvaptan, and what the effect (PD) of the various doses of Tolvaptan are on the content of "salt" in blood and urine
- Trial name
- NCT02009878
- Testing
- tolvaptan
- Where
- 14 sites in Czechia, Denmark and 5 more
- Volunteers
- 30 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Diabetes, Healthy
Within-subject Variability of Insulin Detemir in Healthy Volunteers
This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.
- Trial name
- NCT01497535
- Testing
- insulin detemir, insulin glargine
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Novo Nordisk A/S
Solid Tumor, Adult
A Trial of BI 765063 Monotherapy and in Combination With BI 754091 in Patients With Advanced Solid Tumours
This trial will be a two steps Phase I clinical study in patients with advanced solid tumors with an escalating phase (Step 1) followed by an expansion phase (Step 2) of BI 765063, a monoclonal antibody (mAb) antagonist to signal…
- Trial name
- NCT03990233
- Testing
- BI 765063, BI 754091
- Where
- 8 sites in Belgium, France
- Volunteers
- 100 people
- Sponsor
- OSE Immunotherapeutics
Advanced Solid Tumors
Study of AMG 256 in Adult Subjects With Advanced Solid Tumors
To evaluate the safety and tolerability of AMG 256 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
- Trial name
- NCT04362748
- Testing
- AMG 256
- Where
- 11 sites in United States, Australia and 2 more
- Volunteers
- 34 people
- Sponsor
- Amgen
Acute Lymphoblastic Leukaemia, Acute Myeloid Leukaemia
Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression
The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic…
- Conditions
- Acute Lymphoblastic Leukaemia, Acute Myeloid Leukaemia, Higher-risk Myelodysplastic Syndromes
- Trial name
- MOMENTUM (NCT07155226)
- Testing
- AZD3632, Posaconazole
- Where
- 30 sites in United States, Australia and 7 more
- Volunteers
- 85 people
- Sponsor
- AstraZeneca
Schizophrenia
A First In Human Study Of PF-00184562 In Healthy Volunteers
The purposes of this study are: To determine the safety, tolerability and pharmacokinetics of single doses of PF-00184562; and To explore the exposure-response relationship of neuropsychometric and tolerability measures of…
- Trial name
- NCT00150215
- Testing
- PF-00184562, Olanzapine
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Osteogenesis Imperfecta
Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta
This is a randomized, open label intra-patient dose escalation study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of BPS804 in adults with osteogenesis imperfecta (OI).
- Trial name
- NCT01417091
- Testing
- BPS804
- Where
- 6 sites in United States, Belgium and 2 more
- Volunteers
- 10 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Pelizaeus-Merzbacher Disease
Orbit Study: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Intrathecally Administered ION356 in Participants With Pelizaeus Merzbacher Disease (PMD)
The primary purpose of this study is to evaluate the safety and tolerability of ION356.
- Trial name
- NCT06150716
- Testing
- ION356
- Where
- 7 sites in United States, France and 3 more
- Volunteers
- 24 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Idiopathic Parkinson's Disease
Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes
The purpose of this study is to determine the safety, efficacy and pharmacokinetics following administration of CVT-301 in treatment of "off" episodes in Parkinson's Disease patients.
- Trial name
- NCT01617135
- Testing
- CVT-301, Sinemet (carbidopa/levodopa)
- Where
- 7 sites in Israel, Serbia and 1 more
- Volunteers
- 25 people
- Sponsor
- Acorda Therapeutics
Hepatitis C, Chronic
Dose Ranging of GSK2336805 in Combination Therapy
GSK2336805 is a novel hepatitis C virus (HCV) non-structural 5A (NS5A) inhibitor being developed for the treatment of chronic HCV infection.
- Trial name
- HAI115879 (NCT01648140)
- Testing
- GSK2336805 40 mg, GSK2336805 60 mg, Pegylated interferon alpha-2a
- Where
- 34 sites in United States, Belgium and 4 more
- Volunteers
- 286 people
- Sponsor
- GlaxoSmithKline
Cancer, Neoplasms
A Phase I, 2-part (Part 1 Being a Single Dose Escalation and Part 2, a Parallel Group) Study of Toll-like Receptor (TLR4) Agonist (GSK1795091) in Healthy Subjects
This study is an ascending dose first-time-in-human study to determine the safety, tolerability, pharmacodynamic (PD), and pharmacokinetics (PK) profile of GSK1795091 in healthy subjects.
- Trial name
- NCT02798978
- Testing
- GSK1795091
- Where
- Germany
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pulmonary Disease, Chronic Obstructive
A 2 Part Study Examining Doses Of GSK961081 In Healthy Volunteers And Then In COPD Patients
GSK961081 has previously been administered to healthy subjects in a nebulised formulation and the first part of this study which will be conducted in healthy subjects proposes to bridge the change from nebulised to DPI…
- Trial name
- NCT00478738
- Testing
- GSK961081
- Where
- 5 sites in Germany, South Africa
- Volunteers
- 82 people
- Sponsor
- GlaxoSmithKline
Mucopolysaccharidosis Type II (MPS II)
CAMPSIITE™ RGX-121 Gene Therapy in Subjects With MPS II (Hunter Syndrome)
RGX-121 is a gene therapy which is intended to deliver a functional copy of the iduronate-2-sulfatase gene (IDS) to the central nervous system.
- Trial name
- NCT03566043
- Testing
- RGX-121
- Where
- 5 sites in United States, Brazil
- Volunteers
- 48 people
- Sponsor
- REGENXBIO Inc.
Intragastric Acidity
Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)
This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day…
- Trial name
- NCT01077076
- Testing
- Zegerid, Prilosec OTC™ Tablets
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bayer
Arthritis, Rheumatoid, Healthy
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy
To evaluate the safety and tolerability of multiple doses of BI 655064 administered subcutaneously in healthy volunteers (HVs) and in rheumatoid arthritis (RA) patients.
- Trial name
- NCT01751776
- Testing
- BI 655064
- Where
- 25 sites in Czechia, Germany and 4 more
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Neoplasms, Melanoma
A Study of Modakafusp Alfa (TAK-573) Given by Itself and Together With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
This study has 2 phases. The main aims of Phase 1b are: to check for side effects from modakafusp alfa in adults with locally advanced or metastatic solid tumors.
- Trial name
- NCT04157517
- Testing
- Modakafusp Alfa, Pembrolizumab
- Where
- 17 sites in United States, Australia
- Volunteers
- 45 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Chronic Idiopathic Urticaria
Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria
The study is to evaluate the profiles of safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221. In this study, safety profile of UB-221 and maximum tolerated dose (MTD) is to be investigated using sentinel dosing…
- Trial name
- NCT04175704
- Testing
- UB-221
- Volunteers
- 32 people
- Sponsor
- United BioPharma
Moderate-to-severe Atopic Dermatitis
Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis
This Phase 1a/1b randomized, double-blind, placebo-controlled study evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously (SC) administered TRB-061 in healthy adults and patients with…
- Trial name
- NCT06934252
- Testing
- TRB-061
- Where
- 19 sites in Australia, New Zealand
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- TRex Bio, Inc.
Hepatic Insufficiency
Pharmacokinetics and Pharmacodynamics of BI 1356 in Subjects With Different Degrees of Liver Impairment as Compared to Healthy Subjects
To investigate the influence of mild, moderate, and severe liver impairment on the pharmacokinetics and pharmacodynamics of linagliptin in comparison with a control group with normal hepatic function after single or multiple oral…
- Trial name
- NCT02183376
- Testing
- BI 1356
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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