Clinical trials: PK in Healthy Volunteers
Healthy Participants, Hepatic Impairment
Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function
The purpose of the study is to compare the single dose PK of casdatifan between participants with moderate hepatic impairment (HI) and healthy matched control participants with normal hepatic function.
- Trial name
- NCT07751250
- Testing
- Casdatifan
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Arcus Biosciences, Inc.
Healthy
Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets
This is a Phase 1 Relative Bioavailability Study Comparing The Pharmacokinetics Of Aramchol Meglumine (AM) Granules For Oral Suspension To Aramchol Free Acid (AA) 300 mg Tablets In Healthy Volunteers
- Trial name
- NCT06502561
- Testing
- Aramchol meglumine, Aramchol free acid
- Where
- Bulgaria
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Galmed Pharmaceuticals Ltd
Healthy
Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females
This is a pharmacokinetics and safety study over 3 weekly applications.
- Trial name
- NCT01422135
- Testing
- AG200-15
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics
Atopic Dermatitis
SAD/MAD Safety and PK Study of RBN-3143 in Healthy and Atopic Dermatitis Subjects
RBN-3143 Background: PARP proteins are members of a family of seventeen ADP-ribosyltransferase (ART) enzymes that regulate cellular processes including gene expression, protein degradation, and multiple cellular stress responses.
- Trial name
- NCT05215808
- Testing
- RBN-3143
- Where
- 6 sites in Australia, New Zealand
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Ribon Therapeutics, Inc.
Healthy
Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects
The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and…
- Trial name
- NCT01208753
- Testing
- GLPG0555, GLPG0555 aqueous
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs), Healthy Participants
A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants
This study will evaluate bioavailability and food effect of selumetinib (AZD6244) in healthy male participants. A total of 24 healthy male participants will be included to ensure at least 20 evaluable participants.
- Trial name
- NCT03649165
- Testing
- Treatment A, Treatment B, Treatment C
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Pharmacokinetics
A Study to Determine the Effects of Itraconazole on the Pharmacokinetics (PK) of DS-8500 in Healthy Subjects
Study will assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a in healthy subjects. This is an open-label study in healthy subjects.
- Trial name
- NCT02790671
- Testing
- DS-8500a, Itraconazole
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Healthy Subjects
PK and Safety Comparison of DWJ445 and DWC202506 in Healthy Volunteers
A bioequivalence study comparing DWJ1445 and DWC202506 in healthy adults
- Trial name
- NCT07256600
- Testing
- DWJ1445, DWC202506
- Where
- South Korea
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Tuberculosis, Tuberculosis, Pulmonary
A Phase 1 Study to Evaluate Safety, Tolerability, PK, and PK Interactions of TBA-7371
The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of TBA-7371 in healthy subjects
- Trial name
- NCT03199339
- Testing
- TBA-7371
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Asthma
Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the…
- Trial name
- NCT01737892
- Testing
- Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation, Arm C-Epinephrine Inhalation Aerosol CFC
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Amphastar 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
HIV Infections
The Raltegravir and Ribavirin Pharmacokinetics (PK) Study
The purpose of this study is to look at levels of both a new anti-HIV drug called raltegravir and an existing anti-hepatitis C drug called ribavirin to see if they affect the blood levels of each other when given separately and…
- Trial name
- NCT00982553
- Testing
- Ribavirin, Raltegravir
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)
A Phase I Study Evaluating Safety, Tolerability, PK and PD of BL-8040 for Stem Cell Mobilization in Healthy Volunteers
The purpose of this study is to determine whether BL-8040 is safe, tolerable and effective in the mobilization of Hematopoietic Stem Cells (HSC) in healthy volunteers
- Trial name
- NCT02073019
- Testing
- BL-8040
- Where
- Israel
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- BioLineRx, Ltd.
Hepatic Impairment
PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
The purpose of this international study was to assess the effect of varying degrees of impaired hepatic function compared to a normal hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of midostaurin.
- Trial name
- NCT01429337
- Testing
- Midostaurin
- Where
- 7 sites in United States, Belgium and 4 more
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy Volunteers
A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.
- Trial name
- NCT06487572
- Testing
- Risankizumab
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- AbbVie
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
Parkinson's Disease
A Study to Evaluate the Safety, Tolerability, PK and PD of HNC364 Injectable Suspension
This is a non-randomized, dose-escalation first-in-human study to evaluate the safety, tolerability, PK, and PD of HNC364 following intramuscular administration of single ascending doses.
- Trial name
- NCT05523570
- Testing
- HNC364
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.
Bacterial Infections
P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants
A Phase 1, Open-Label, Drug-drug Interaction, and Randomized, Double-blind, Controlled, Multiple-dose Pharmacokinetics and Safety Study of Xeruborbactam Oral Prodrug (QPX7831) in Combination with Ceftibuten in Healthy Adult…
- Trial name
- NCT06079775
- Testing
- Xeruborbactam Oral Prodrug, Ceftibuten
- Where
- Australia
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Qpex Biopharma, Inc.
Healthy Subjects
A Study To Assess The Safety, Tolerability, And Pharmacokinetics (PK) Of Multiple Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects
This will be an investigator- and subject-blinded (sponsor open), randomized, placebo controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional sixth and seventh cohorts).
- Trial name
- NCT03230383
- Testing
- PF-06865571
- Where
- 2 sites in United States, Belgium
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Safety, Tolerability, PK, PD, ADA of Escalating Single Dose of CJ-40002 in Healthy Male Subjects
The objectives of this study are: To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy male volunteers. To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers.
- Trial name
- hGH (NCT02146625)
- Testing
- CJ-40002
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
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