Clinical trials: Healthy Adult Subjects
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.
Ebola Virus
Vaccine Treatment for Ebola Virus in Healthy Adults (V920-001)
This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (Zaire ebolavirus) also known as V920 and BPSC-1001.
- Trial name
- NCT02269423
- Testing
- V920
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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 Volunteers
A Study to Evaluate Drug-Drug Interaction of TAK-788 With Itraconazole and Rifampin in Healthy Adult Participants
The purpose of this study is to characterize the effect of itraconazole (Part 1) and rifampin (Part 2) on the single-dose pharmacokinetics (PK) of TAK-788 and its active metabolites (AP32960 and AP32914) in healthy adult…
- Trial name
- NCT03928327
- Testing
- TAK-788, Itraconazole, Rifampin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy
A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults
This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Molybdenum.
- Trial name
- NCT05319899
- Testing
- ALXN1840, Omeprazole
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy Subjects
Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers
Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.
- Trial name
- NCT01199965
- Testing
- MAP0004, IV DHE
- Where
- United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Allergan
Healthy Adult Subjects
A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy Subjects
To evaluate the effect of MCI-186 on the QT interval corrected for heart rate using Fridericia's formula (QTcF)
- Trial name
- NCT04029090
- Testing
- MCI-186
- Where
- Japan
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Shionogi
Clinical Pharmacology
TAK-114 Single- and Multiple-Dose Phase 1 Study
The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese male participants.
- Trial name
- NCT02286518
- Testing
- TAK-114 10 mg capsule
- Where
- Japan
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Healthy
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of PF-04958242 in Healthy Subjects
The purpose of the current study is to characterize the pharmacokinetic (PK) profile of PF 04958242 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor.
- Trial name
- NCT02341482
- Testing
- PF-04958242, Itraconazole
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Adult Subjects
A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants
The purpose of this study is to assess how fast pegilodecakin gets into the blood stream and how long it takes the body to remove it, when given as a solution formulation via a prefilled syringe (PFS) versus from a vial drawn…
- Trial name
- Willow 3 (NCT04194892)
- Testing
- Pegilodecakin
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
Study of the Effects of Itraconazole and Rifampin on LOXO-305 in Healthy Participants
The main purpose of this study is to learn about how itraconazole and rifampin affect LOXO-305 in healthy participants. Participation could last about 8 weeks.
- Trial name
- NCT05134337
- Testing
- LOXO-305, Itraconazole, Rifampin
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Loxo Oncology, Inc.
Healthy
First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants
The primary purpose of this study was to investigate the safety and tolerability of M5717 and to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and parasite clearance in healthy participants…
- Trial name
- NCT03261401
- Testing
- M5717
- Where
- Australia
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy Participants
A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants
The purpose of this study is to evaluate the effect of the potent CYP3A4 inhibitor itraconazole on the single-dose PK of TAK-954.
- Trial name
- NCT03173170
- Testing
- TAK-954, Itraconazole
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Takeda
Tumor
Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults
The primary objective of the study was to investigate the relative bioavailability and pharmacokinetics (PK) of sitravatinib free base and malate salt capsule formulations following oral administration in healthy adults.
- Trial name
- NCT04472650
- Testing
- Sitravatinib
- Where
- Australia
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- BeiGene
Infections, Bacterial
Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects
This is double-blind, randomized, sequential, two part study. Part 1 is a 3 periods, fixed-sequence study and will be conducted to evaluate the pharmacokinetics, safety, and tolerability of the gepotidacin tablet in healthy adult…
- Trial name
- NCT04079790
- Testing
- Gepotidacin
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants.
The purpose of this study is to evaluate bioavailability of lanadelumab (SHP643) following a single, 2 milliliter (mL) subcutaneous (SC) dose of 300 milligrams (mg) delivered by prefilled syringe (PFS) or auto injector (AI) in…
- Trial name
- NCT03918239
- Testing
- SHP643
- Where
- United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Shire
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.
Healthy
Desmopressin Acetate 0.2 mg Tablets, Fasting
The objective of this study was to compare the single-dose relative bioavailability of TEVA and Aventis Pharmaceuticals (DDAVP®) 0.2 mg desmopressin acetate tablets following a 0.8 mg dose under fasting conditions.
- Trial name
- NCT00835211
- Testing
- Desmopressin Acetate 0.2 mg Tablets, DDAVP® 0.2 mg Tablets
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence, Healthy Subjects
Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine])…
- Trial name
- NCT05014490
- Testing
- Exib 120 mg etoricoxib film-coated tablets, Arcoxia® 120 mg etoricoxib film-coated tablets
- Where
- Turkey (Türkiye)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Darnitsa Pharmaceutical Company