Clinical trials: Pharmacodynamics
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
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
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
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)
Sleep Initiation and Maintenance Disorders
A Study of LY2624803 in Japanese Participants With Transient Insomnia
The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy Japanese participants. The study has four treatment periods.
- Trial name
- NCT01784614
- Testing
- LY2624803 - Solution, LY2624803 - Capsule
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes
This is a randomised, cross-over, open-label, confinement study conducted in 24 adult male or female smokers of combustible cigarettes.
- Trial name
- NCT05459857
- Testing
- Product A, Product B, Product C
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Imperial Brands PLC
Psoriasis
Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.
- Trial name
- NCT00867100
- Testing
- 700 mg IV, 350 mg SC, 140 mg SC
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Diabetes Mellitus, Type 2
A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects
The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties of single oral doses of DBPR108 in healthy male subjects.
- Trial name
- NCT01650324
- Testing
- DBPR108
- Where
- Taiwan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- National Health Research Institutes, Taiwan
Healthy
A Study of LY3185643 and rGlucagon in Healthy Participants
The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and what effects LY3185643 and rGlucagon have on the body. This study will also help to determine if LY3185643 is safe and well-tolerated.
- Trial name
- NCT02951780
- Testing
- LY3185643, rGlucagon
- Where
- Singapore
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Study of ALXN1820 in Healthy Adult Participants
This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1820…
- Trial name
- NCT04631562
- Testing
- ALXN1820 SC, ALXN1820 IV
- Where
- 3 sites in Australia, United Kingdom
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
A Study of a Single Dose of ALXN1210 in Healthy Participants
This study evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of ALXN1210 in healthy participants, as assessed by electrocardiograms, physical examination, vital signs, laboratory…
- Trial name
- NCT05288660
- Testing
- ALXN1210
- Where
- Canada
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy Volunteers
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 3 of 4)
The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.
- Trial name
- NCT03551730
- Testing
- PRT064445/Enoxaparin
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Plaque Psoriasis
A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis
This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis.
- Trial name
- NCT03210961
- Testing
- PF-06826647 tablet, PF-06826647 oral suspension
- Where
- United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Pfizer
Immunogenicity, Healthy Volunteers
Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Intas Pharmaceuticals Ltd.
- Trial name
- NCT04015232
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Non-Alcoholic Steatohepatitis
Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in overweight and obese adults.
- Trial name
- NCT02287779
- Testing
- SHP626
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Mirum Pharmaceuticals, Inc.
Migraine
Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and Migraine Patients
The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients.
- Trial name
- NCT01688739
- Testing
- Erenumab
- Where
- Belgium
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Volunteer
A Pharmacodynamic Study to Evaluate Neutrophil Distribution Kinetics and Function Following Single-Dose RoActemra/Actemra (Tocilizumab) in Healthy Volunteers
This Phase IV, single-blind , randomized, two-arm study will explore the pharmacodynamics effects of RoActemra/Actemra (tocilizumab) on neutrophil redistribution, function and survival in healthy subjects.
- Trial name
- NCT01991990
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy
To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1467335 Following Multiple Dose Administration Over 28 Days
The primary objective of this trial is to investigate the safety and tolerability of BI 1467335 in healthy male and female subjects following oral administration of multiple rising doses over 28 days.
- Trial name
- NCT02733627
- Testing
- BI 1467335
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Impairment, Type 2 Diabetes Mellitus
Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)
This is a study to evaluate the effect of renal impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and in healthy participants with…
- Trial name
- NCT01948986
- Testing
- Ertugliflozin
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Subjects, Pharmacokinetics
Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors
This study is designed to assess pharmacokinetics and pharmacodynamics of evolocumab and alirocumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology…
- Conditions
- Healthy Subjects, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT04189484
- Testing
- Evolocumab, Alirocumab
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)