Clinical trials: Open-label
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)
Healthy
Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects
To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration
- Trial name
- NCT01426958
- Testing
- afatinib, ritonavir + afatinib
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Interpandemic Influenza
Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009
Trial for annual approval of interpandemic influenza vaccines
- Trial name
- NCT00734734
- Testing
- Seasonal Influenza Vaccine
- Where
- 2 sites in Italy
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Healthy
To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted…
- Trial name
- NCT01101321
- Testing
- Reformulated OXY (Totowa) (oxycodone HCl), Reformulated OXY (Wilson) (oxycodone HCl)
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
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
Smoking
Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L
The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, and the safety and tolerability of the nicotine-containing aerosol delivered by Platform 3 Liquid…
- Trial name
- NCT02532374
- Testing
- Nicorette® inhalator, P3L
- Where
- New Zealand
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.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
Dengue
Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine
The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
- Trial name
- NCT00290147
- Testing
- D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
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.
Healthy Volunteers
Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application
Comparative PK study after single SC application of Afolia and the reference product (US Gonal-f®). Objective: To demonstrate equivalence within 80%-125% margin of the reference product for the area under the curve (AUC) of…
- Trial name
- NCT02459418
- Testing
- Afolia, US Gonal-f®
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Fertility Biotech AG
Relapse Remitting Multiple Sclerosis
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes.
- Trial name
- AGNOS (NCT05084638)
- Testing
- Ofatumumab
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C, Chronic
A Study of the Pharmacokinetics of Uprifosbuvir (MK-3682) and Ruzasvir (MK-8408) in Participants With Moderate and Severe Hepatic Insufficiency (MK-3682-029)
This is a non-randomized, open-label, single-dose study to evaluate the pharmacokinetics (PK) of uprifosbuvir (MK-3682), the M5 and M6 metabolites of uprifosbuvir, and ruzasvir (MK-8408), in participants with moderate hepatic…
- Trial name
- NCT02666352
- Testing
- Uprifosbuvir, Ruzasvir
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Fever, Pain
Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subjects Under Fasting Conditions
This study aims to evaluate the bioequivalence of new formulated orodispersible tablet (ODT) containing 500 milligram (mg) paracetamol in comparison to the European marketed Alvedon (paracetamol) 500 mg film-coated tablets and…
- Trial name
- NCT06855576
- Testing
- Paracetamol ODT, Alvedon film-coated tablet, Panadol film-coated Tablet
- Where
- Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- HALEON
Smoking, Tobacco
Nicotine Pharmacokinetics of THS Single Use of a Regular or a Menthol Stick Compared to CIG
The purpose of this study was to describe the nicotine pharmacokinetic (PK) profile during and after single use of THS (Induction heating technology, with either a regular or menthol stick) compared to singular CIG smoking in…
- Trial name
- NCT05789420
- Testing
- P1R stick, P1M stick, CIG
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Healthy, Primary Immune Thrombocytopenia
A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347
This phase 1 single ascending dose study will provide a first in human assessment of safety and tolerability of PF-06755347 in healthy adult males as well as adult males and females with Immune Thrombocytopenia (ITP).
- Conditions
- Healthy, Primary Immune Thrombocytopenia, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- Trial name
- NCT03275740
- Testing
- PF-06755347 intravenous healthy participant, PF-06755347 subcutaneous healthy participant, PF-06755347 subcutaneous ITP
- Where
- 6 sites in United States, Belgium and 3 more
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]-PF-07304814 in Healthy Participants
This open-label, single dose study in approximately 5 healthy male and female (of non childbearing potential only) participants has been designed to characterize mass balance and further the understanding of human…
- Trial name
- NCT05050682
- Testing
- PF-07304814
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Drug-Drug Interaction Study: ASP2151 and Midazolam
CYP3A4 is involved in the metabolism of many drugs. So, it is important to assess in vivo the induction effect of ASP2151 on that enzyme to determine the extent of any possible drug interactions.
- Trial name
- NCT02403635
- Testing
- Midazolam, ASP2151
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Maruho Europe Limited
Melanoma, BRAF V600 Mutation
Bioequivalence Binimetinib 3 x 15 mg and 45 mg Formulations
The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration.
- Conditions
- Melanoma, BRAF V600 Mutation, Unresectable Melanoma, Metastatic Melanoma
- Trial name
- NCT05810740
- Testing
- Binimetinib 15 MG, Binimetinib 45 MG
- Where
- France
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
Neoplasm, Advanced or Metastatic
A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants
The purpose of this study is to evaluate the relative bioavailability of a new tablet formulation of TAK-117 (new clinical trial material [NTM]) compared to the TAK-117 Process B capsules (current clinical trial material [CTM])…
- Trial name
- NCT02625259
- Testing
- TAK-117, Lansoprazole
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Renal Impairment
Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function
A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.
- Trial name
- NCT01740362
- Testing
- CP-690,550
- Where
- 4 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
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