Clinical trials: Pharmacodynamics
Pediatric Growth Hormone Deficiency, Growth Disorders
Versartis Trial in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) to Assess Long-Acting Growth Hormone (Somavaratan, VRS-317)
The trial will consist of three stages: 1) a 30 day Phase 2 PK and PD evaluation of somavaratan, 2) an optional Phase 2 Extension and 3) a 12 month Phase 3 safety and efficacy stage.
- Trial name
- NCT02413138
- Testing
- Somavaratan (VRS-317)
- Where
- Japan
- Volunteers
- 41 people
- Sponsor
- Versartis Inc.
Healthy Participants
Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®
Single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®
- Trial name
- NCT06492226
- Testing
- NKF-INS(A), EU-NovoRapid®, US-NovoLog®
- Where
- South Africa
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Xentria, Inc.
Type 1 Diabetes Mellitus
Pediatric Diabetics Type 1 Using InsuPatch
This study is a prospective, single-center, open label, randomized; two-arms cross over study. This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is…
- Trial name
- NCT01368978
- Testing
- InsuPatch
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Insuline Medical Ltd.
Healthy Volunteer
Open-label Safety and PK Study of BION-1301 in Japanese Healthy Subjects
Phase 1, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of multiple doses of BION-1301 in Japanese healthy subjects.
- Trial name
- NCT05508204
- Testing
- BION-1301
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Chinook Therapeutics, Inc.
Parkinson's Disease
Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's Disease
This is a multicenter, randomized, double-blind, placebo-controlled study of multiple ascending iv doses of MEDI341 in male and female subjects with Parkinson's Disease.
- Trial name
- NCT04449484
- Testing
- MEDI1341
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- AstraZeneca
Molybdenum Cofactor Deficiency Type A
Study of cPMP (Precusor Z) to Treat Molybdenum Cofactor Deficiency (MoCD) Type A
Molybdenum Cofactor Deficiency Type A (MoCD) is a very rare autosomal recessive disorder that is essentially fatal early in life. Naturally occurring cPMP is present in the body of all healthy normal individuals.
- Trial name
- NCT00957749
- Testing
- cPMP
- Where
- Australia
- Volunteers
- 10 people
- Sponsor
- Orphatech Pharmaceuticals, GmbH
Cancer, Solid Tumors
Dose Escalation Study of Safety and Tolerability of AT-406 in Patients With Advanced Solid Tumors and Lymphomas
The purpose of this study is to determine the safety profile and the maximum dose of Debio 1143 (AT-406) that can be given to humans.
- Conditions
- Cancer, Solid Tumors, Lymphoma, Malignancy
- Trial name
- NCT01078649
- Testing
- Debio 1143 (AT-406)
- Where
- 3 sites in United States
- Volunteers
- 51 people
- Sponsor
- Debiopharm International SA
Myotonic Dystrophy 1
Safety, Tolerability, PK, and PD Study of PGN-EDODM1 in Participants With Myotonic Dystrophy Type 1
The primary purpose of the study is to evaluate the safety and tolerability of single intravenous (IV) doses of PGN-EDODM1 administered to participants with Myotonic Dystrophy Type 1 (DM1).
- Trial name
- FREEDOM-DM1 (NCT06204809)
- Testing
- PGN-EDODM1 for infusion
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 24 people
- Sponsor
- PepGen Inc
Arthritis, Rheumatoid Arthritis
To Evaluate the Blood Levels and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis Using Methotrexate
The primary objectives are to determine the relationship between blood levels of CDP6038 and suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV) infusion or subcutaneous (SC) injection to…
- Trial name
- NCT01009242
- Testing
- CDP6038, CDP 6038 SC, Methotrexate
- Where
- 6 sites in United States, Germany
- Volunteers
- 40 people
- Sponsor
- UCB Pharma
Sickle Cell Disease
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512.
- Trial name
- NCT06546670
- Testing
- ITU512
- Where
- 14 sites in United States, Brazil and 1 more
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Type 1 Diabetes Mellitus
Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of subcutaneously administered teplizumab in adults with relatively recent onset T1DM, greater than 12 weeks and…
- Trial name
- SUBCUE (NCT01189422)
- Volunteers
- 1 people
- Sponsor
- MacroGenics
Health Volunteer
A Single and Multiple Ascending Doses Study to Evaluate the Safety and Pharmacokinetics of RBD5044
This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability, PK profiles and PD effect of single and multiple ascending doses of subcutaneously administered RBD5044 in healthy…
- Trial name
- NCT05539651
- Testing
- RBD5044
- Where
- Australia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Suzhou Ribo Life Science Co. Ltd.
Healthy Participants
A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants
The purpose of this study is to characterize andexanet posology and interaction between andexanet and enoxaparin post infusion in healthy participants.
- Trial name
- NCT07312851
- Testing
- Andexanet alfa, Rivaroxaban, Apixaban
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 191 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteer
A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers
This single-center, randomized, double-blind, four-period crossover study will investigate the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy volunteers.
- Trial name
- NCT01543529
- Testing
- RO4917838, Alcohol
- Where
- France
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Alzheimer Disease, Healthy
Study GSI-136 in Healthy Young and Healthy Elderly Subjects
This is a first-in-humans study of GSI-136, a drug being developed for the treatment of Alzheimer Disease. The main purpose of this study is to determine whether GSI-136 is safe and tolerable in healthy young and healthy elderly…
- Trial name
- NCT00718731
- Testing
- GSI-136
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hepatocellular Carcinoma, Renal Cell Carcinoma
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
This is a research study of an experimental drug called ACC-1898. ACC-1898 is an oral tyrosine kinase inhibitor (TKI) that blocks several proteins kinases which may help cancer cells grow and spread.
- Conditions
- Hepatocellular Carcinoma, Renal Cell Carcinoma, Thyroid Carcinoma, Medullary, Thyroid Carcinoma Primary Differentiated
- Trial name
- NCT07252661
- Testing
- ACC-1898
- Volunteers
- 40 people
- Sponsor
- AccSalus Biosciences, Inc.
Neoplasms
A Trial to Evaluate Epothilone D in Patients With Advanced Solid Tumors
Epothilone D represents one of a class of cytotoxic macrolides capable of causing mitotic arrest by stabilizing tubulin polymerization.
- Trial name
- NCT00030173
- Testing
- Epothilone D (KOS-862)
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Bristol-Myers Squibb
Healthy
Multiple Oral Doses of BIBR 1048 MS Solution in Healthy Volunteers
To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters.
- Trial name
- NCT02170831
- Testing
- BIBR 1048 MS low, BIBR 1048 MS medium 1, BIBR 1048 MS medium 2
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study of Multiple Doses of ALXN1210 in Healthy Adult Participants
This study evaluated the safety and tolerability of multiple doses of ALXN1210 (400 and 800 milligrams [mg]) following intravenous (IV) administration to healthy participants.
- Trial name
- NCT05288673
- Testing
- ALXN1210
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Metastatic Melanoma and Other Solid Tumors
A Study to Learn How Safe BAY2666605 is, How it Affects the Body, How it Moves Into, Through and Out of the Body, the Maximum Amount That Can be Given and Its Action Against Tumors in Adult Participants With Skin Cancer That Has Spread to Other Parts of the Body and Other Types of Advanced Cancer
Researchers are looking for a better way to treat people who have advanced cancer. In this study researchers want to learn more about a new substance called BAY2666605.
- Trial name
- NCT04809805
- Testing
- BAY2666605
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Bayer
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