Clinical trials: Pharmacokinetics
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
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
Healthy Volunteers, Renal Impairment
Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Subjects (MK-6183-001)
The purpose of this study is to characterize the effect of renal function on the plasma, urine, and dialysate pharmacokinetic profile of MK-6183 (CB-238,618) in humans.
- Trial name
- NCT02341599
- Testing
- MK-6183
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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.
Solid Tumors
A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.
This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.
- Trial name
- NCT04642365
- Testing
- RO7296682, Atezolizumab
- Where
- 10 sites in United States, Australia and 4 more
- Volunteers
- 49 people
- Sponsor
- Hoffmann-La Roche
Congenital Bleeding Disorder, Haemophilia A
A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A
This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who…
- Trial name
- pathfinder™5 (NCT01731600)
- Testing
- turoctocog alfa pegol
- Where
- 51 sites in United States, Brazil and 14 more
- Volunteers
- 68 people
- Sponsor
- Novo Nordisk A/S
Healthy
A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)
This is a Phase 1, open label, fixed sequence study of the effect of multiple dose PF-06650833 on single dose OC PK in healthy female subjects.
- Trial name
- NCT05064332
- Testing
- PF-06650833, Ethinyl estradiol (EE) and levonogestrel (LN)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Pfizer
Schizophrenia, Schizoaffective Disorder
Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Schizophrenia
This study in patients with schizophrenia is designed to provide preliminary evidence of the safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2 doses of EVP-6124 compared with placebo…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Central Nervous System Diseases
- Trial name
- NCT01556763
- Testing
- EVP-6124 (0.3 mg/day), EVP-6124 (1.0 mg/day), Antipsychotic therapy
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- FORUM Pharmaceuticals Inc
Attention Deficit Hyperactivity Disorder
Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules in Pediatric Participants With Attention-deficit Hyperactivity Disorder (ADHD)
With the pharmacokinetics (PK) of centanafadine currently being evaluated in adults. The PK of extended-release centanafadine may differ in children compared to adults due to physiological differences in the gastrointestinal…
- Trial name
- NCT04081363
- Testing
- Centanafadine
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Depression
Trial to Determine the Maximum Tolerated Dose (MTD) Based on Safety and Tolerability, of Org 26576 in Participants With Major Depressive Disorder (174001/P05704/MK-8777-001)
Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.
- Trial name
- NCT00610649
- Testing
- MK-8777
- Volunteers
- 54 people
- Sponsor
- Merck Sharp & Dohme LLC
Non-Hodgkin's Lymphoma
A Study of Dulanermin in Combination With Rituximab in Subjects With Follicular and Other Low Grade, CD20+, Non-Hodgkin's Lymphomas
This Phase Ib/II, open-label, multicenter trial is designed to evaluate the safety, pharmacokinetics, and efficacy of dulanermin when combined with rituximab in subjects with follicular, CD20+, B-cell Non-Hodgkin's Lymphoma (NHL)…
- Trial name
- NCT00400764
- Testing
- Dulanermin, Rituximab
- Volunteers
- 72 people
- Sponsor
- Genentech, Inc.
Kidney Failure, Chronic, Renal Insufficiency, Chronic
A Study of LY2409021 in Participants With Different Levels of Kidney Function
The purpose of this study was to measure how much of the study drug, LY2409021, gets into the blood stream and how long it takes the body to get rid of it when given to participants with different levels of kidney function.
- Trial name
- NCT01929109
- Testing
- LY2409021
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Cancer, Advanced
Pharmacokinetics of Ridaforolimus (MK-8669) in Chinese Participants (MK-8669-059)
Part 1 of the study will assess the pharmacokinetics, safety, and tolerability of ridaforolimus (MK-8669) after administration of single and multiple 40 mg doses in Chinese participants with advanced cancer.
- Trial name
- NCT01380184
- Testing
- ridaforolimus
- Volunteers
- 15 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Influence of Bosentan on the Pharmacokinetics of Nintedanib
The trial was designed to investigate whether, and to which extent, multiple doses of bosentan may influence the plasma levels of nintedanib administered as a single dose.
- Trial name
- NCT02667704
- Testing
- Bosentan, Nintedanib
- Where
- Germany
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
HIV Infections
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide…
- Trial name
- NCT00076999
- Testing
- TPV oral solution, RTV oral solution
- Where
- 30 sites in United States, Argentina and 8 more
- Volunteers
- 115 people
- Sponsor
- Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF (SAD).
Assess the safety of CHF10067 (study drug) and any side effects that might be associated with it. The study also evaluated how much of the study drug gets into the bloodstream and how long the body takes to remove it.
- Trial name
- NCT05513950
- Testing
- CHF10067 starting dose -- 1000mg (Cohort A), CHF10067 intermediate dose -- 2000mg (Cohort B), CHF10067 high dose -- 3000mg (Cohort C)
- Where
- 9 sites in North Macedonia, Ukraine and 1 more
- Volunteers
- 52 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Kidney Disease
Pharmacokinetics of Verinurad and Allopurinol in Combination With Cyclosporine and Rifampicin in Healthy Volunteers
This Phase 1 study aims to quantify the effects of cyclosporine, a broad transporter inhibitor, and rifampicin, an OATP1B1/3 inhibitor, on verinurad pharmacokinetics (PK).
- Trial name
- NCT04532918
- Testing
- Verinurad, Allopurinol, Cyclosporine
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Warm Autoimmune Hemolytic Anemia, Cold Agglutinin Disease
Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD).
- Trial name
- NCT03226678
- Testing
- APL-2
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
Covid19
Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)
This clinical pharmacology study will evaluate the relative bioavailability, safety, and tolerability of two different concentrations of sotrovimab injections administered at different injection sites in male or female healthy…
- Trial name
- COSMIC (NCT05280717)
- Testing
- sotrovimab
- Where
- 10 sites in United States
- Volunteers
- 316 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
Hepatitis C, Chronic
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic…
- Trial name
- NCT02765490
- Testing
- AL-335, Odalasvir, Simeprevir
- Where
- 28 sites in Belgium, Canada and 4 more
- Volunteers
- 365 people
- Sponsor
- Janssen Research & Development, LLC
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