Clinical trials: Drug Toxicity
Drug Toxicity
Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics of KD101 in Healthy Male Subjects
To Evaluate the safety and tolerability after KD101 single oral dosing in healthy male subjects To Evaluate the pharmacokinetic property after KD101 single oral dosing in healthy male subjects To Evaluate the effect of food on…
- Trial name
- NCT01979380
- Testing
- KD101
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Kwang Dong Pharmaceutical co., ltd.
Chemotherapy, Nerve Degeneration
Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs
The study hypothesis is that changes in serially obtained nerve conduction study data obtained every 3-4 weeks in cancer patients receiving chemotherapy can be used to predict the development of a clinically significant /…
- Conditions
- Chemotherapy, Nerve Degeneration, Nerve Conduction
- Trial name
- NCT01208545
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- NeuroMetrix, Inc.
Drug Toxicity
Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
Arm 1: Primary Objective: To determine the safety and tolerability of multiple ascending, supratherapeutic doses of HPN-100. Arm 2: Primary Objective: To assess the effects of steady-state levels of HPN-100 metabolites (4…
- Trial name
- NCT01135680
- Testing
- HPN-100, Moxifloxacin
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Amgen
Drug/Agent Toxicity by Tissue/Organ, Lymphoma
Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma
RATIONALE: Denileukin diftitox may be able to deliver cancer-killing substances directly to T-cell lymphoma cells. Dexamethasone may decrease the side effects of denileukin diftitox.
- Trial name
- NCT00006345
- Testing
- denileukin diftitox, dexamethasone
- Where
- 11 sites in United States
- Sponsor
- Ligand Pharmaceuticals
Small Cell Lung Cancer, Soft Tissue Sarcoma
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells.
- Conditions
- Small Cell Lung Cancer, Soft Tissue Sarcoma, Triple-negative Breast Cancer, Ovarian Cancer
- Trial name
- EDO-S101 (NCT03345485)
- Testing
- Tinostamustine 60mg/m2 over 30min, Tinostamustine 80mg/m2 over 30min, Tinostamustine 100mg/m2 over 30min
- Where
- 13 sites in United States, Canada and 3 more
- Volunteers
- 71 people
- Sponsor
- Mundipharma Research Limited
Mood Disturbance, Mood Change
Mood and Cognitive Effects of Psilocybin in Healthy Participants
This study is seeking to find the optimal microdose or low dose of psilocybin (magic mushrooms) that provides general enhancements to mood, memory, sleep, and other measures of general well-being without any hallucinogenic…
- Conditions
- Mood Disturbance, Mood Change, Sleep Disturbance, Drug Effect
- Trial name
- MELO (NCT05252598)
- Testing
- Psilocybin, Inonotus Obliquus Whole Extract
- Volunteers
- healthy volunteers welcome
- Sponsor
- Optimi Health Corporation
Cancer-related Fatigue, Neutropenia, Malignant
PG2 Breast Cancer Evaluation in Adjuvant Medicine Study
Adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are at significant risk for disseminated disease. Chemotherapy has been demonstrated to reduce the risk of breast cancer recurrence.
- Trial name
- PG2 BEAM (NCT03314805)
- Testing
- Astragalus polysaccharides 500 mg, EC Chemotherapy
- Where
- 5 sites in Taiwan
- Volunteers
- 67 people
- Sponsor
- PhytoHealth Corporation
Ophthalmological Agent Toxicity
Evaluation of Manzanilla® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes
Demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue.
- Trial name
- NCT06859476
- Testing
- Manzanilla Sophia®, Meticel Ofteno® 0.5%
- Where
- Mexico
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Natural Blood and Blood Product Toxicity
A Randomized, Double-blinded, Active Controlled Crossover Clinical Trial to Investigate PK, PD and Safety of GBPD002
Erythropoietin (EPO) biosimilarity for GBPD002 (test candidate) and Eprex® (comparator) has been evaluated by comparing the pharmacokinetic (PK) and pharmacodynamic (PD) properties following subcutaneous injection in human…
- Trial name
- NCT05585658
- Testing
- Erythropoietin alpha
- Where
- 2 sites in Bangladesh
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Globe Biotech Limited
Mucositis, Nephrotoxicity
Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients.
- Conditions
- Mucositis, Nephrotoxicity, Ototoxicity
- Trial name
- NCT03480971
- Testing
- Tempol
- Where
- 9 sites in United States
- Volunteers
- 120 people
- Sponsor
- Matrix Biomed, Inc.
Hepatic Encephalopathy, Acute on Chronic Liver Failure (ACLF)
A Study to See if an Investigational Medicine Called VS-01 Can Help and How Safe it is in the Treatment of Patients With Overt Hepatic Encephalopathy
A Phase 2, Randomized, Controlled, Open-Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care versus Standard…
- Conditions
- Hepatic Encephalopathy, Acute on Chronic Liver Failure (ACLF), Decompensated Cirrhosis
- Trial name
- NCT06987968
- Testing
- VS-01 on top of SOC (Active Treatment Group), SOC
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 3 people
- Sponsor
- Genfit
Colorectal Neoplasms, Diarrhea
Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer
The triple combination chemotherapy of irinotecan, 5-fluorouracil and leucovorin (CPT-11/5-FU/LV or Saltz regimen) is the treatment of choice for patients with advanced colorectal cancer.
- Trial name
- NCT00036517
- Testing
- PHY906
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- PhytoCeutica
Drug/Agent Toxicity by Tissue/Organ, Pancreatic Cancer
Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.
- Trial name
- NCT00024427
- Testing
- fluorouracil, gemcitabine hydrochloride, triacetyluridine
- Where
- 29 sites in United States, Canada
- Volunteers
- 250 people
- Sponsor
- Wellstat Therapeutics
Ophthalmological Agent Toxicity, Bacterial Conjunctivitis
Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects
This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best…
- Trial name
- NCT06363292
- Testing
- PRO-231, VIGAMOXI®
- Where
- Mexico
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Stage III Melanoma
Interferon Toxicities in Melanoma Treatment
The primary objective of this study is to quantify and compare the prevalence of adverse events (AEs) in patients with stage III melanoma before and after initiation of interferon (IFN) therapy in a real-world setting.
- Trial name
- ITMT (NCT02794636)
- Volunteers
- 436 people
- Sponsor
- Bristol-Myers Squibb
Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis
Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were confirmed based on the investigators national diagnostic criteria.
- Trial name
- NCT01696500
- Testing
- Intravenous immunoglobulin
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- Nihon Pharmaceutical Co., Ltd
Hand Foot Skin Syndrome
Topical Cosmetic Products for Hand and Foot Syndrome
The aim of the study is to evaluate the efficacy of a dermocosmetic protocol in reducing the main cutaneous side effects that occur in palmar-plantar erythrodysesthesia syndrome in subjects with a tumor diagnosis, undergoing…
- Trial name
- NCT06586073
- Testing
- cosmetic products
- Where
- Italy
- Volunteers
- 53 people
- Sponsor
- Dermophisiologique s.r.l
Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Peripheral neuropathy is a disorder caused by damage to the peripheral nerves. Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of certain chemotherapy drugs, such as platinum-based compounds, taxanes…
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain, CIPN - Chemotherapy-Induced Peripheral Neuropathy, Peripheral Neuropathic Pain
- Trial name
- NCT07072468
- Testing
- VMD-3866 Gel
- Where
- United Kingdom
- Volunteers
- 16 people
- Sponsor
- VM Therapeutics LLC
Hepatitis C
Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan
- Trial name
- NCT03071133
- Where
- Japan
- Volunteers
- 344 people
- Sponsor
- Bristol-Myers Squibb
Neoplasms, Medication Toxicity
Study of Orally-Administered AMXT 1501 Dicaprate in Normal Healthy Volunteers
This is a Phase 1 study, which will assess the safety, PK, and pharmacodynamics (PD) of orally-administered AMXT 1501 dicaprate in normal healthy male volunteers.
- Conditions
- Neoplasms, Medication Toxicity, Tolerance
- Trial name
- NCT03077477
- Testing
- AMXT 1501
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Aminex Therapeutics, Inc.