Clinical trials: Safety and Pharmacokinetics
Infections, Bacterial
A Three-part Study to Determine the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Volunteers and Healthy Male Japanese Subjects
The primary objectives of this study are to assess the safety, tolerability and pharmacokinetics of GSK1322322 following intravenous (IV) and oral administration.
- Trial name
- NCT01818011
- Testing
- GSK1322322 Initial fit for purpose tablets, GSK1322322 over granulated tablets, GSK1322322 intended commercial tablets
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV-1, Human Immunodeficiency Virus 1
MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and anti-retroviral activity of MK-8510 monotherapy in anti-retroviral-naïve HIV-1 infected participants.
- Conditions
- HIV-1, Human Immunodeficiency Virus 1, Immunodeficiency Virus Type 1, Human, Human Immunodeficiency Virus Type 1
- Trial name
- NCT05700734
- Testing
- MK-8510
- Sponsor
- Merck Sharp & Dohme LLC
End Stage Renal Disease on Hemodialysis
Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis
This is a Phase 1, single-arm, open-label study to evaluate the safety, PK, and tolerability of a repeated (3 times weekly) dose of difelikefalin administered as IV bolus injections to adult Chinese HD subjects.
- Trial name
- NCT05885763
- Testing
- Difelikefalin Injection
- Where
- 4 sites in China
- Volunteers
- 30 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
Schizophrenia
In-Patient Study In Schizophrenic Patients
This study is a placebo-controlled study to assess the safety and tolerability of a novel antipsychotic medication, (773812) when given to schizophrenic patients for twenty-eight days.
- Trial name
- NCT00197093
- Testing
- SB773812
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Healthy
Study to Assess Effect of Cyclosporine on the Blood Levels of Ticagrelor
The purpose of this study is to assess the effect of Cyclosporine on the blood levels of Ticagrelor.
- Trial name
- NCT01504906
- Testing
- cyclosporine, ticagrelor
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Advanced Colorectal Carcinoma
4SC-201 (Resminostat) in Advanced Colorectal Carcinoma
The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of 4SC-201 (Resminostat) in combination with FOLFIRI and whether 4SC-201 (Resminostat) is effective and safe in combination FOLFIRI versus FOLFIRI alone…
- Trial name
- SHORE (NCT01277406)
- Testing
- 4SC-201(Resminostat), FOLFIRI
- Where
- 3 sites in Germany
- Volunteers
- 17 people
- Sponsor
- 4SC AG
Metastatic Prostate Cancer
64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study)
This is a Phase 1 trial of TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592).
- Trial name
- CUPID (NCT04726033)
- Testing
- 64Cu-DOTA-TLX592
- Where
- 2 sites in Australia
- Volunteers
- 14 people
- Sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
Essential Hypertension
Study of the Product QGC001 as a Single Dose and Multiple Doses Administered Orally to Healthy Adult Subjects
1QG2 is a Phase 1 study aiming to assess the safety and tolerability of ascending single/multiple oral doses (SAD \& MAD) in healthy young subjects, the preliminary food interaction and the effect of QGC001 on blood pressure and…
- Trial name
- NCT01900184
- Testing
- QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]
- Where
- France
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Quantum Genomics SA
Dravet Syndrome
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome
The primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.
- Trial name
- ORCHID (NCT06118255)
- Testing
- fenfluramine
- Where
- 12 sites in United States, Belgium and 3 more
- Volunteers
- 25 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Schizophrenia
A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072 (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.
- Trial name
- NCT01493726
- Testing
- ALKS 9072, Low dose, ALKS 9072, Med dose, ALKS 9072, High dose
- Where
- 6 sites in United States
- Volunteers
- 88 people
- Sponsor
- Alkermes, Inc.
Neoplasms, Colorectal
Study of Pazopanib, Irinotecan and Cetuximab in Combination to Treat 2nd Line Metastatic Colorectal Cancer
Subjects will be entered into cohorts of 3 for the dose escalation phase so that the maximum tolerated dose can be determined. 18 additional patients will be recruited once the maximum tolerated dose (MTD) is determined for…
- Trial name
- NCT00540943
- Testing
- Pazopanib, Cetuximab, Irinotecan
- Where
- 2 sites in France
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Lymphoma, Non-Hodgkin
Copanlisib Chinese PK Study
This study will be conducted primarily to determine the pharmacokinetics of copanlisib in Chinese patients with relapsed iNHL. The primary objective of the study is to determine the pharmacokinetics of copanlisib administered on…
- Trial name
- NCT03498430
- Testing
- Copanlisib (Aliqopa, BAY80-6946)
- Where
- China
- Volunteers
- 13 people
- Sponsor
- Bayer
Advanced Solid Tumours
The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour.
This is a 2 parts phase I, open label trial of olaparib monotherapy and olaparib in combination with paclitaxel in patients with solid tumours.
- Trial name
- NCT02430311
- Testing
- Olaparib, Paclitaxel
- Where
- 3 sites in China
- Volunteers
- 36 people
- Sponsor
- AstraZeneca
Dementia, Frontotemporal
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VES001 in Healthy Participants
This is a Phase 1, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of VES001 in a two part followed by a…
- Trial name
- SORT-IN-1 (NCT06226064)
- Testing
- VES001
- Where
- Netherlands
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Vesper Biotechnologies ApS
Head and Neck Cancer
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy
The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.
- Trial name
- NCT00540332
- Testing
- palifermin
- Sponsor
- Swedish Orphan Biovitrum
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated and Taken up by the Body With or Without Food
The main objectives of the single rising doses (SRD) trial part are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1819479 in healthy male subjects following administration of single rising doses.
- Trial name
- NCT04801693
- Testing
- BI 1819479
- Where
- Germany
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hypoplasminogenemia, Congenital Plasminogen Deficiency
A Study of Prometic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia
This is a Phase 2/3 pivotal study to evaluate pharmacokinetics (PK), efficacy, and safety of Prometic Plasminogen (Human) Intravenous Lyophilized Solution, the investigational medicinal product (IMP), in pediatric and adult…
- Trial name
- NCT02690714
- Testing
- Plasminogen (Human) intravenous
- Where
- 2 sites in United States, Norway
- Volunteers
- 15 people
- Sponsor
- Prometic Biotherapeutics, Inc.
Healthy Subjects
Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules
This study is divided into two parts: the safety, tolerability, pharmacokinetic profiles of LV232 capsules after multiple ascending doses (hereinafter referred to as "PK characteristics of multiple ascending doses study ") and…
- Trial name
- NCT06279533
- Testing
- LV232
- Where
- China
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Vigonvita Life Sciences
Postoperative Pain Management in Total Knee Arthroplasty
Phase Ⅱ Study of Adductor Canal Block With HR18034 for Postsurgical Pain Management in TKA
Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection adductor canal block with HR18034 for postoperative pain management in total knee…
- Trial name
- NCT06509958
- Testing
- HR18034, Ropivacaine Hydrochloride Injection
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Advanced Solid Tumor
Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors
ONC-783-001 is a Phase I open label, dose-escalation study for evaluating the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced/metastatic solid tumors, focusing on colorectal…
- Trial name
- NCT07408258
- Testing
- ONC-783
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- OncoC4, Inc.
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