Clinical trials: Safety and Pharmacokinetics
Type 2 Diabetes Mellitus
Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes
Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus.
- Trial name
- NCT00103935
- Testing
- Exenatide LAR
- Where
- 7 sites in United States
- Volunteers
- 45 people
- Sponsor
- AstraZeneca
Healthy
A Study to Learn About the Medicine Called PF-08653944 in People With and Without Reduced Liver Function
This study is being done to learn more about an investigational medicine called PF-08653944. The goal is to understand how the body handles the medicine and to check its safety after a single dose.
- Trial name
- NCT07519135
- Testing
- PF-08653944
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer
Refractory or Recurrent CD30+ Hematologic Malignancies
A Study of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.
This is a Phase I dose escalation study designed to define the maximum tolerable dose(MDT), the safety profile, pharmacokinetic parameters, immunogenicity and anti-tumor activity of F0002-ADC in Chinese patients with…
- Trial name
- NCT03894150
- Testing
- F0002-ADC
- Where
- 2 sites in China
- Volunteers
- 45 people
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Renal Transplantation
Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.
- Trial name
- NCT01064791
- Testing
- sotrastaurin (Dose 1) + tacrolimus + standard of care medications, sotrastaurin (Dose 2) + tacrolimus + standard of care medications, sotrastaurin (Dose 3) + tacrolimus + standard of care medications
- Where
- 44 sites in United States, Argentina and 13 more
- Volunteers
- 298 people
- Sponsor
- Novartis Pharmaceuticals
Safety, Bioavailability
Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation
This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a…
- Conditions
- Safety, Bioavailability, Pharmacokinetics
- Trial name
- BA (NCT05627518)
- Testing
- Linaprazan glurate
- Where
- Slovenia
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
Ataxia Telangiectasia
Comparative Bioavailability of Betamethasone Oral Solution Metered Spray (GTX-102) in Healthy Subjects
A Randomized, Open-label, Crossover Study to Evaluate the Comparative Bioavailability, Pharmacokinetics, and Safety of GTX-102 Administered as an Oral Spray Compared to Intramuscular Injection - betamethasone and an Oral Solution…
- Trial name
- NCT05531890
- Testing
- GTX-102 medium dose fast Period 1 and Period 2, GTX-102 medium dose slow Period 1 and Period 2, GTX-102 high dose fast Period 1 and Period 2
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Grace Therapeutics Inc.
Healthy Participants
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO7062931 in Healthy Chinese Volunteers.
This randomized study will evaluate the safety, tolerability and pharmacokinetics of single ascending subcutaneously administered doses of RO7062931 in healthy volunteers.
- Trial name
- NCT03505190
- Testing
- RO7062931
- Where
- 2 sites in Hong Kong
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
- Trial name
- NCT06745297
- Testing
- BI 3776528, short-acting benzodiazepine
- Where
- Germany
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Centronuclear Myopathy
Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies
There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)/preliminary efficacy of…
- Trial name
- Unite-CNM (NCT04033159)
- Testing
- DYN101
- Where
- 8 sites in Belgium, Denmark and 4 more
- Volunteers
- 14 people
- Sponsor
- Dynacure
Refractory Solid Tumors
Phase 1, Multiple Dose Study of MPC-6827 in Subjects With Refractory Solid Tumors
Phase 1, Multiple Dose Study of MPC-6827 in Subjects with Refractory Solid Tumors.
- Trial name
- NCT00394446
- Testing
- MPC-6827
- Where
- 2 sites in United States
- Volunteers
- 48 people
- Sponsor
- Myrexis Inc.
Infections
Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults
This study is designed to evaluate the pharmacokinetics (PK) of a single 3 gm dose of cefazolin from a DUPLEX container, in adult subjects (weighing >/= 120 kg) scheduled for surgery.
- Trial name
- 3gCefPK (NCT05205486)
- Testing
- Cefazolin 3gm for Injection USP and Dextrose Injection USP
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- B. Braun Medical Inc.
Advanced Melanoma
A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin
The aim of the study BCD-263-1 is to prove the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-263 and Opdivo following intravenous administration to subjects…
- Trial name
- NCT06112808
- Testing
- BCD-263, Opdivo
- Where
- 30 sites in Belarus, Russia
- Volunteers
- 300 people
- Sponsor
- Biocad
Alcoholic Hepatitis
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe…
- Trial name
- AH (NCT03432260)
- Testing
- DUR-928 30 mg, DUR-928 90 mg, DUR-928 150 mg
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- Durect
Endometriosis Related Pain, Overactive Bladder
Study on the Safety of BAY1817080, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug in Participants With Impaired Liver Function or Normal Liver Function
BAY1817080 is currently under clinical development to treat pain related to unexplained chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained chronic cough, RUCC), or a condition where the…
- Conditions
- Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain, Refractory or Unexplained Chronic Cough
- Trial name
- NCT04454424
- Testing
- BAY1817080, Midazolam
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- Bayer
Healthy Volunteer
A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers
This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or…
- Trial name
- NCT02711423
- Testing
- Gantenerumab
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Subjects
Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects
This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only)…
- Trial name
- NCT03980080
- Testing
- OSE-127
- Where
- Belgium
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- OSE Immunotherapeutics
Myotonic Dystrophy Type 1 (DM1)
Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-101 in Participants With Myotonic Dystrophy Type 1
The primary purpose of the study is to evaluate the safety and tolerability of multiple intravenous (IV) doses of DYNE-101 administered to participants with Myotonic Dystrophy Type 1 (DM1).
- Trial name
- ACHIEVE (NCT05481879)
- Testing
- DYNE-101
- Where
- 20 sites in United States, Australia and 6 more
- Volunteers
- 127 people
- Sponsor
- Dyne Therapeutics
Healthy Subjects
A Study in Healthy Subjects to Assess the Safety and Tolerability of a 120-hour Continuous Infusion of M6229
This is a Phase I, single-center, randomized, single-blind, placebo-controlled study in healthy subjects assessing the safety, tolerability and pharmacokinetic profile of three different dose levels of M6229 when administered…
- Trial name
- NCT07285603
- Testing
- M6229
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Matisse Pharmaceuticals
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.
Pharmacokinetics, Cancer
Safety, Tolerability and Pharmacokinetics Study of MK-7252 in Healthy Adult Participants (MK-7252-001)
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of MK-7252 in healthy adults. Participants receive ascending doses of MK-7252 over five treatment periods.
- Trial name
- NCT03326986
- Testing
- MK-7252
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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