Clinical trials: Healthy Males
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
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
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
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
Compare IBI305 and Bevacizumab on Pharmacokinetics/Safety/Immunogenicity on Healthy Male
To confirm the PK similarity of IBI305 and bevacizumab in healthy volunteers .
- Trial name
- NCT03083990
- Testing
- IBI305(Bevacizumab Biosimilar), Avastin(Bevacizumab)
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Healthy
Fasting Bioavailability Study of Lovastatin Tablets and Mevacor Tablets
The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose…
- Trial name
- NCT00685685
- Testing
- Lovastatin 40 mg tablets, Lovastatin (Mevacor®) 40 mg Tablets
- Where
- Canada
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers
Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.
- Trial name
- NCT01119443
- Testing
- PPX ER
- Where
- Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
The main objective of this trail is to investigate if and to what extent BI 409306, BI 425809 and lamotrigine attenuate ketamine induced cognitive deficits.
- Trial name
- NCT04602221
- Testing
- Lamotrigine, BI 409306, BI 425809
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test How Different Doses of BI 474121 Are Taken up and How They Influence the Amount of a Molecular Messenger (cGMP) in the Spinal Fluid
The main objectives of this trial are: To evaluate the effect of BI 474121 on cyclic guanosine monophosphate (cGMP) levels in cerebrospinal fluid (CSF) To assess the exposure of BI 474121 in CSF relative to plasma To determine…
- Trial name
- NCT04672954
- Testing
- 2.5 milligram (mg) BI 474121, 10 milligram (mg) BI 474121, 20 milligram (mg) BI 474121
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Impairment
Study of a Single Intravenous (IV) Dose of MK-3402 in Participants With Impaired Renal Function and in Healthy Controls (MK-3402-004)
The purpose of this study is to compare the plasma and urine pharmacokinetics (PK) of MK-3402 in participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3402 is removed…
- Trial name
- NCT04678505
- Testing
- MK-3402
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Heart Failure
Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide
Primary Trial objectives: To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in 50 healthy, male volunteers after single intravenous administration (8 subjects on verum per dose…
- Trial name
- COR-1-01 (NCT01043146)
- Testing
- COR-1
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Corimmun GmbH
Healthy Volunteers
A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, PD, safety and immunogenicity profile of MB09 with EU/US-Xgeva® in healthy male subjects.
- Trial name
- NCT05299073
- Testing
- MB09, US-sourced Xgeva, EU-sourced Xgeva
- Where
- Poland
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- mAbxience Research S.L.
Bioequivalence
Bioequivalence Study of Favipiravir 200 mg Film Tablet (ATABAY, Turkey) Under Fasting Conditions
A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting…
- Trial name
- Favipiravir (NCT04406194)
- Testing
- FAVICOVIR 200 mg Film Tablet, AVIGAN 200 mg Film Tablets
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Atabay Kimya Sanayi Ticaret A.S.
Healthy
Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.
The objective of the current study is to demonstrate bioequivalence of two 2.5 mg linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination of the linagliptin 5 mg and metformin 1000 mg in…
- Trial name
- NCT01947153
- Testing
- Metformin, Linagliptin
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1358894 in the Blood
The main objective of this trial is to investigate the relative bioavailability of BI 1358894 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as…
- Trial name
- NCT03843151
- Testing
- BI 1358894, Itraconazole
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Safety, Tolerability
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 After Single Ascending Doses to Healthy Males
This study will be a randomized, single-blind, placebo-controlled first-in-human study in healthy male subjects to assess the safety, tolerability and pharmacokinetics of single ascending doses of AZD9977.
- Conditions
- Safety, Tolerability, Pharmacokinetics, Healthy Subjects
- Trial name
- NCT02484729
- Testing
- AZD9977, oral suspension, AZD9977, oral solution
- Where
- United Kingdom
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Wilson's Disease
Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily).
A randomised, open-label study evaluating the pharmacokinetics, safety, and tolerability of a new once daily dose of 900mg of TETA 4HCL by comparing it against the current marketed Cuprior® formulation (450mg trientine base…
- Trial name
- NCT06128954
- Testing
- 900mg TETA 4HCl Once Daily Formulation, 900mg TETA 4HCl Cuprior®
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Orphalan
Healthy
This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills
The primary objective of this trial is to establish the bioequivalence of two empagliflozin/linagliptin/metformin extended release (XR) fixed dose combination (FDC) tablets (Test, T) compared with the same doses of the individual…
- Trial name
- NCT03629054
- Testing
- Empagliflozin, Metformin HCl, Linagliptin (fixed dose combination), Empagliflozin, Linagliptin
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim