Clinical trials: Safety and Pharmacokinetics
Huntington's Disease
A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single or repeat doses of ALN-HTT02.
- Trial name
- NCT06585449
- Testing
- ALN-HTT02
- Where
- 19 sites in Canada, Germany and 1 more
- Volunteers
- 66 people
- Sponsor
- Alnylam Pharmaceuticals
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Antitumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate Alone and in Combination With Darolutamide, in Patients With Metastatic Castration Resistant Prostate Cancer
The study medication (BAY 2315497 Injection) is a thorium-227 labeled immuno-conjugate, specific for the prostate-specific membrane antigen (PSMA), which will be evaluated in patients with metastatic castration resistant prostate…
- Trial name
- NCT03724747
- Testing
- BAY2315497 Injection, Darolutamide(BAY1841788)
- Where
- 5 sites in United States, Finland and 1 more
- Volunteers
- 63 people
- Sponsor
- Bayer
Advanced Solid Tumor
A Study of HB0030 Injection in Patients With Advanced Solid Tumors
This is a phase Ia single-center, open-label, dose escalation study.The objectives of this study are to evaluate the safety, toxicity, tolerability, pharmacokinetics/pharmacodynamics(PK/PD), immunogenicity, biomarkers, and…
- Trial name
- NCT05706207
- Testing
- HB0030 injection
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Huabo Biopharm Co., Ltd.
Malaria, Falciparum, Malaria, Vivax
Efficacy of SJ733 in Adults With Uncomplicated Plasmodium Falciparum or Vivax Malaria
This Phase 2a trial recruits adult patients with uncomplicated P. vivax or P. falciparum blood-stage malaria mono-infection. The study drug SJ733 will be administered to examine its antimalarial efficacy, safety, and…
- Trial name
- NCT04709692
- Testing
- (+)-SJ000557733 (SJ733)
- Where
- Peru
- Volunteers
- 22 people
- Sponsor
- R. Kiplin Guy
Gastrointestinal Stromal Tumors, Advanced Systemic Mastocytosis
A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies
This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of DCC-2618, administered…
- Conditions
- Gastrointestinal Stromal Tumors, Advanced Systemic Mastocytosis, Advanced Cancers
- Trial name
- NCT02571036
- Testing
- DCC-2618
- Where
- 26 sites in United States, Canada and 4 more
- Volunteers
- 282 people
- Sponsor
- Deciphera Pharmaceuticals, LLC
Leishmaniasis
Safety and Drug Absorption of Orally Administered Oleylphosphocholine (OlPC) in Healthy Adults
The goal of this interventional study is to assess the safety and tolerability of OlPC and to characterize the pharmacokinetics (PK) of OlPC following single, ascending doses administered orally in healthy-fed subjects.
- Trial name
- NCT06124144
- Testing
- Oleylphosphocholine
- Where
- Germany
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- University Hospital Tuebingen
Hypercholesterolemia
Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels
The aim of this study is to assess the safety and tolerability of varying dose and load regimens of ISIS 301012 in people who have elevated LDL-cholesterol levels.
- Trial name
- NCT00216463
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Kastle Therapeutics, LLC
HIV Infections
Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children
Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find an appropriate dose of EFZ to use in combination with…
- Trial name
- NCT00000893
- Testing
- Nelfinavir mesylate, Efavirenz
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 103 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hypertension, Hyperlipidemia
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus Co-administration of a Fixed Dose Combination of…
- Trial name
- NCT02569814
- Testing
- Fimasartan/Amlodipine/Rosuvastatin, Fimasartan/Amlodipine, Rosuvastatin
- Where
- South Korea
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Solid Tumours
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Renal Impaired Subjects and Healthy Subjects
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in subjects with renal impairment and healthy subjects
- Trial name
- NCT02063204
- Testing
- selumetinib
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy, Elderly
A Study to Evaluate Safety, Tolerability, Plasma Drug Levels, and Cognitive Response Following Multiple Doses of a Drug in Healthy Elderly Participants.
Evaluate the safety and tolerability of PF-04447943 after administration of multiple doses in healthy elderly participants. Evaluate plasma drug levels and effects on cognition.
- Trial name
- NCT00832052
- Testing
- PF-04447943
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pfizer
Elevated Blood Pressure, Hypertension
HJB647 Phase 1b Study in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacokinetics, and pharmacodynamics of HJB647 following single dose administration in Japanese healthy participants with elevated blood…
- Trial name
- NCT07644364
- Testing
- HJB647
- Where
- Japan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Sickle Cell Disease
A Study to Evaluate GBT021601-012 Single Dose and Multiple Dose in Participants With Sickle Cell Disease (SCD)
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK), and pharmacodynamics (i.e., how the body absorbs, distributes, breaks down, and excretes) of GBT021601, a hemoglobin S (HbS)…
- Trial name
- NCT04983264
- Testing
- GBT021601
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Pfizer
Advanced Solid Tumor
Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors
This is an open label, phase 1 clinical study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended phase 2 dose (RP2D) of QLS31904…
- Trial name
- NCT05461287
- Testing
- QLS31904
- Where
- China
- Volunteers
- 290 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Gaucher Disease
A Study of the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single dosing study with three ascending dose cohorts of ISU302 in healthy subjects.
- Trial name
- NCT01881633
- Testing
- ISU302
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ISU Abxis Co., Ltd.
Diabetes Mellitus, Diabetes Mellitus, Type 2
Multiple Dose Study of PF-04991532 in Patients With Type 2 Diabetes
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04991532 following multiple (14 days) escalating oral doses in patient wtih type 2 diabetes.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
- Trial name
- NCT01129258
- Testing
- PF-04991532
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Pfizer
Solid Tumors, Non-Small Cell Lung Cancer
Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors
HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity of HS-20117 in combination with other…
- Conditions
- Solid Tumors, Non-Small Cell Lung Cancer, Colorectal Cancer
- Trial name
- HS-20117 (NCT06621563)
- Testing
- HS-20117 combined HS-20093, HS-20117 combined Platinum-containing chemotherapy, HS-20117 combined HS-20093 and 5-FU
- Where
- China
- Volunteers
- 780 people
- Sponsor
- Hansoh BioMedical R&D Company
Uterine Fibroids
Pharmacokinetics and Hepatic Safety of EGCG
A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.
- Trial name
- NCT04177693
- Testing
- Epigallocatechin gallate (EGCG), Clomiphene Citrate, Letrozole
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Yale University
Healthy
This Study Tests How Different Doses of BI 690517 Are Taken up in the Body of Healthy Men. The Study Also Looks at How Food Influences the Amount of BI 690517 in the Blood
The primary objective of the trial is to investigate the safety and tolerability of BI 690517 in healthy male subjects following oral administration of multiple rising doses over 14 days (MRD part).
- Trial name
- NCT03100916
- Testing
- BI 690517, BI 690517 (Reference)
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Triple-Negative Breast Neoplasms, Breast Neoplasm
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and…
- Conditions
- Triple-Negative Breast Neoplasms, Breast Neoplasm, Breast Cancer, Triple-Negative Breast Cancer
- Trial name
- NCT02978716
- Testing
- Trilaciclib, Gemcitabine, Carboplatin
- Where
- 54 sites in United States, Belgium and 6 more
- Volunteers
- 102 people
- Sponsor
- G1 Therapeutics, Inc.
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