Clinical trials: Pharmacokinetics
Healthy
A Study of LY3463251 in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen.
- Trial name
- NCT03764774
- Testing
- LY3463251
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Male Subjects
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male…
- Trial name
- NCT05245669
- Testing
- ENZ215, EU Sourced Prolia, US Sourced Prolia
- Where
- 2 sites in Bulgaria, Poland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Enzene Biosciences Ltd.
Healthy
To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin
This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product CT-P16 with EU-approved Avastin and US-licensed…
- Trial name
- NCT03247673
- Testing
- CT-P16, EU-approved Avastin, US-licensed Avastin
- Where
- 3 sites in South Korea
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Celltrion
Healthy
A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics and pharmacodynamics of BI 3731579 in healthy volunteers following administration of multiple rising doses per day over 15 days.
- Trial name
- NCT06716190
- Testing
- Mid-dose bid BI 3731579, Midazolam, Low-dose bid BI 3731579
- Where
- Belgium
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Safety, Bioavailability
Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation
This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a…
- Conditions
- Safety, Bioavailability, Pharmacokinetics
- Trial name
- BA (NCT05627518)
- Testing
- Linaprazan glurate
- Where
- Slovenia
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
Healthy Participants
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO7062931 in Healthy Chinese Volunteers.
This randomized study will evaluate the safety, tolerability and pharmacokinetics of single ascending subcutaneously administered doses of RO7062931 in healthy volunteers.
- Trial name
- NCT03505190
- Testing
- RO7062931
- Where
- 2 sites in Hong Kong
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
This study aims to investigate the effect of multiple doses of BI 1358894 on pharmacokinetics of ethinylestradiol (EE) and drospirenone (DRSP) (Yasmin®)
- Trial name
- NCT05934942
- Testing
- Yasmin®, BI 1358894
- Where
- Germany
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Infections
Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults
This study is designed to evaluate the pharmacokinetics (PK) of a single 3 gm dose of cefazolin from a DUPLEX container, in adult subjects (weighing >/= 120 kg) scheduled for surgery.
- Trial name
- 3gCefPK (NCT05205486)
- Testing
- Cefazolin 3gm for Injection USP and Dextrose Injection USP
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- B. Braun Medical Inc.
Healthy
A Study in Healthy Men to Test How Zongertinib (BI 1810631) is Taken up and Processed by the Body
Part A - the primary objective is to assess the mass balance and total recovery of [14C]-radioactivity in urine and faeces after oral single dose administration of BI 1810631 (C-14) (test treatment T1) in healthy male subjects.
- Trial name
- NCT05879991
- Testing
- zongertinib (C-14), zongertinib
- Where
- Netherlands
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Pharmacokinetics, Cancer
Safety, Tolerability and Pharmacokinetics Study of MK-7252 in Healthy Adult Participants (MK-7252-001)
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of MK-7252 in healthy adults. Participants receive ascending doses of MK-7252 over five treatment periods.
- Trial name
- NCT03326986
- Testing
- MK-7252
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
This Study Tests the Safety, Tolerability and How Different Doses of BI 1265162 Are Taken up in the Body of Healthy Men
The primary objective of this trial is to investigate the safety and tolerability of BI 1265162 in healthy male subjects following inhalative administration of single rising doses.
- Trial name
- NCT03349723
- Testing
- BI 1265162
- Where
- Germany
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Orthopoxviral Disease
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers.
- Trial name
- 246-Safety (NCT00907803)
- Testing
- ST-246 400 mg, ST-246 600 mg
- Where
- 3 sites in United States
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
Hepatic Impairment, Healthy Volunteers
STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of PF-06882961
- Trial name
- NCT04604496
- Testing
- PF-06882961 20MG
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment, Healthy Volunteers
A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function
The main aim is to check the effect of a single dose of soticlestat in adults with moderate or mild liver failure compared to healthy adults with normal liver function. Participants will check into the study clinic for 8 days.
- Trial name
- NCT05098054
- Testing
- Soticlestat
- Where
- 6 sites in United States, Hungary
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects
The purpose of this first-in-human study is to determine the safety and tolerability profile of CD388 Injection, as compared to saline placebo, when administered as a single dose to healthy adult subjects by injection either in…
- Trial name
- NCT05285137
- Testing
- CD388 Injection
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Dengue
An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge
The investigational study drug, JNJ-64281802, is being developed for the prevention and treatment of dengue infection. This study is hypothesizing that the highest dose of the investigational study drug is superior to receiving a…
- Trial name
- NCT05048875
- Testing
- Cohort 1 - Group 1 JNJ High Dose, Cohort 1 - Group 2 JNJ Medium Dose, Cohort 1 - Group 2 JNJ Low Dose
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteers
A Study of LY3053102 in Healthy Participants
The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants.
- Trial name
- NCT01736241
- Testing
- LY3053102
- Where
- Singapore
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
COVID-19
A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults
This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults.
- Trial name
- NCT04661839
- Testing
- COVID-HIGIV
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Major Depressive Disorder
Phase 1 Evaluation of (2R,6R)-Hydroxynorketamine
A 6-cohort single ascending dose (SAD) study will be conducted in healthy volunteers utilizing a slow-infusion intravenous (IV) route of administration.
- Trial name
- NCT04711005
- Testing
- (2R,6R)-Hydroxynorketamine hydrochloride
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- National Institute of Mental Health (NIMH)
Healthy
Pilot Study of the Pharmacokinetic Profile of Deferiprone Sustained-Release Formulation in Healthy Volunteers
The purpose of this study was to evaluate the pharmacokinetic and safety profile of the sustained-release formulation of deferiprone under both fasting and fed conditions, and evaluate the relative bioavailability of this…
- Trial name
- NCT02189941
- Testing
- Deferiprone sustained-release, Deferiprone immediate-release
- Where
- Canada
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- ApoPharma
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