Clinical trials: PK in Healthy Volunteers
Bladder Cancer
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers
This is an integrated Phase 1, single centre, 2-part, open-label, dose-escalation study conducted in healthy volunteers to assess the safety, tolerability, and PK of APL-1501 ER capsules in comparison to APL-1202 IR tablets.
- Trial name
- NCT06034015
- Testing
- APL-1202 and APL-1501 (Single ascending dose), APL-1202 and APL-1501 (Multiple Ascending dose)
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
Rheumatoid Arthritis
Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects
The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics, and pharmacodynamics following single and multiple ascending oral doses of BMS-986195 in healthy subjects, and to assess the relative…
- Trial name
- NCT02705989
- Testing
- BMS-986195
- Where
- Australia
- Volunteers
- 439 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Compare Bioequivalence Patches Previously Used in the NP101-007 Study
Compare PK and Bioavailability of 2 NP101 Patches With Oral Imitrex in Healthy Adults
The purpose of this research is to: 1. Compare two study patches having minor differences in patch components 2. Compare the pharmacokinetics (PK - how the body absorbs, metabolizes and eliminates medication) of NP101 (study…
- Trial name
- NCT01381796
- Testing
- NP101, sumatriptan succinate
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- NuPathe Inc.
Gastroesophageal Reflux Disease
A Study to Compare PK, PD and Safety of the AD-214 10/600mg and Rabeprazole
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 10/600mg to Rabeprazole 10mg in healthy volunteers.
- Trial name
- NCT04494243
- Testing
- AD-214 10/600mg, Rabeprazole 10mg
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Incontinence
Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects
THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine).
- Trial name
- NCT01036035
- Testing
- Tolterodine, Pilocarpine, THVD-201
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- TheraVida, Inc.
Healthy
Bioequivalence of TF3 and TF2 and Effect of Food on the PK of Tepotinib
The main purpose of the study was to demonstrate bioequivalence between the new tablet formulation (TF3, test treatment) and the tablet formulation used in clinical studies (TF2, reference treatment) and to investigate effect of…
- Trial name
- NCT03629223
- Testing
- Tepotinib TF2, Tepotinib TF3
- Where
- Germany
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hepatitis C Virus Infection
A Study in Healthy Participants Investigating the Safety, Tolerability and Plasma Pharmacokinetics (PK) of Single Oral Doses of JNJ-47910382
The purpose of this study is to investigate the safety, tolerability and plasma pharmacokinetics (PK) of JNJ-47910382 after increasing single oral doses (taken with food) from 10 mg up to 600 mg or up to the maximum tolerated…
- Trial name
- NCT01482611
- Testing
- JNJ-47910382
- Where
- Germany
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Hypertension
Baxdrostat Bioavailability and Bioequivalence Study
The goal of this study was to compare the characteristics of a new tablet formulation versus an oral solution of CIN-107 (baxdrostat) in terms of CIN-107 levels over time in the blood and to compare the effect of food on these…
- Trial name
- NCT05963009
- Testing
- baxdrostat (formerly CIN-107) oral solution
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Depression
PK Study of Diet Effect of Trazodone Hydrochloride Prolonged-Released Tablets in Healthy Chinese
The main objective is to compare the pharmacokinetics in single dose, and effect of food on the trazodone hydrochloride pharmacokinetics prolonged-release tablets.
- Trial name
- NCT02785601
- Testing
- Trazodone Hydrochloride prolonged-release tablets
- Where
- Hong Kong
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Lee's Pharmaceutical Limited
HIV Infections
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants
This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4004280 in healthy adults.
- Trial name
- NCT05163522
- Testing
- VH4004280, Midazolam
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy Volunteer
Safety and PK of Multiple Doses of MT1988
The goal of this clinical trial is to assess the tolerability and amount of drug in the blood when four dose levels of MT1988 are administered for 14 days to healthy volunteers.
- Trial name
- NCT06728176
- Testing
- MT1988
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Monument Therapeutics Limited
Safety Issues
Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers
This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.
- Trial name
- NCT03565861
- Testing
- NP10679
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Neurop Inc.
Bioavailability Study
NPC-12G Gel 0.2% Sirolimus PK Bridging Study
This study is designed to describe the relative systemic bioavailability of topical and oral sirolimus formulations.
- Trial name
- NCT03972462
- Testing
- NPC-12G Gel 0.2%, Rapamune® 2 mg tablet
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Nobelpharma
Healthy Volunteers, Pharmacologic Action
A Phase I Study in Healthy Volunteers to Assess the Effect of Cytochrome3A4 (CYP3A4) Inhibitors (Diltiazem and Itraconazole) on the Pharmacokinetics (PK) of AZD3293 and the Effects of AZD3293 on the Pharmacokinetics of Midazolam, a Cytochrome 3A4 and Cytochrome 3A5 (CYP3A4/CYP3A5) Substrate
This study is a single-center, open-label, 3-group, fixed-sequence drug-drug interaction study to assess the effect of coadministration of multiple-dose itraconazole or diltiazem on the single-dose PK of AZD3293 and the effects…
- Trial name
- AZD3293DDI (NCT02010970)
- Testing
- Group 1 AZD3293, Group 2 AZD3293, Group 3 AZD3293
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers
A Pharmacokinetic (PK) Study Of PF-00299804 And Dextromethorphan In Healthy Volunteers
A study to study the potential effect of PF-00299804 inhibition of CYP2D6 on dextromethorphan.
- Trial name
- NCT00999817
- Testing
- reference [dextromethorphan], test [PF-00299804 + dextromethorphan]
- Where
- Belgium
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
Excretion Balance, PK and Metabolism of a Single Oral Dose of [14C]PCO371
This is a Phase I single center, open-label, non-randomized study in healthy male subjects, designed to evaluate the mass balance recovery, PK, metabolism and absolute bioavailability of single oral doses of PCO371.
- Trial name
- NCT04649216
- Testing
- PCO371, [14C]PCO371
- Where
- United Kingdom
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Chugai Pharmaceutical
Healthy
PK and Safety Study of HCP1102, HGP0813 and HGP1408
This study is a randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of HCP1102 in comparison to HGP0813 and HGP1408 administered in healthy male…
- Trial name
- NCT03371849
- Testing
- montelukast and levocetirizine FDC, Singulair + xyzal
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Healthy Volunteers
A Study to Evaluate the Effect of an Acidic Formulation of Acalabrutinib (ACP-196), Acidic Beverage, or Grapefruit Juice on the Pharmacokinetics (PK) of ACP-196 Alone and Coadministered With Omeprazole
This study will evaluate the effect of an acidic formulation of Acalabrutinib (ACP-196), acidic beverage, or grapefruit Juice on the PK of ACP-196 alone and coadministered with omeprazole.
- Trial name
- NCT04876807
- Testing
- ACP-196, Omeprazole
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Healthy
A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese Subjects
This study will investigate the dose-proportionality of palbociclib pharmacokinetics in healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will receive four single doses of palbociclib…
- Trial name
- NCT02059330
- Testing
- Palbociclib 75mg, Palbociclib 125mg, Palbociclib 100mg
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteer Study
Effect of Carbamazepine on the Pharmacokinetics (PK) of AT-527
This study will determine the effect of carbamazepine on the PK of AT-527 (RO7496998) in healthy adult subjects.
- Trial name
- NCT04784000
- Testing
- Period 1: AT-527 550 mg, Period 2: carbamazepine, Period 3: AT-527 550 mg + carbamazepine
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.