Clinical trials: Pharmacokinetic
Pharmacokinetics
Biomarker Changes and Anxiolytic Effects-Phase 2
This study will examine the utility of plasma and urinary based biomarkers for the anxiolytic properties of kava. The investigators will conduct a one week, double blind, randomized placebo controlled trial of kava, dosed at…
- Trial name
- KavaPK (NCT04565145)
- Testing
- Kava Dietary Supplement
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- University of Florida
Pharmacokinetics
Pharmacokinetic Evaluation of Intranasal Nalmefene
This study is to determine the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given intranasally (IN;into the nose) compared to a dose of nalmefene when given…
- Trial name
- NCT04759768
- Testing
- Nalmefene Hydrochloride, Nalmefene
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Opiant Pharmaceuticals Inc
Pharmacokinetics
A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics
Kava is a dietary supplement on the US market and is experiencing a resurgence of its use. Its pharmacokinetic information, however, is lacking which is important for its future effective usage as a dietary supplement or…
- Trial name
- KavaPK (NCT03843502)
- Testing
- Kava Dietary Supplement
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Florida
COVID-19, Pharmacokinetics
Safety and Acceptability of Q GRFT Nasal Spray for COVID-19 Prophylaxis
This is a phase I randomized, placebo-controlled, single site to assess the local and systemic safety of intranasal Q-Griffithsin (Q-GRFT) after 14 doses in approximately 45 adult participants.
- Conditions
- COVID-19, Pharmacokinetics, Safety
- Trial name
- NCT05180500
- Testing
- Q-Griffithsin
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sharon Hillier
Healthy Subjects, Pharmacokinetics
Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists
This study is designed to assess pharmacokinetics and pharmacodynamics of mepolizumab and reslizumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology…
- Conditions
- Healthy Subjects, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT04183192
- Testing
- Mepolizumab, Reslizumab
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Healthy Subjects, Pharmacokinetics
Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products
This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical…
- Conditions
- Healthy Subjects, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT04183491
- Testing
- Interferon beta-1a, Peginterferon beta-1a
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
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)
Healthy Subjects, Opioid Antagonist
Clinical Study to Investigate the Pharmacokinetics of Multiple Repeated Doses of Intranasal Naloxone
Intranasal (IN) naloxone is available as 2 mg or 4 mg dose with the indication to re-administer additional doses every 2 to 3 minutes (using alternating nostrils) if needed until emergency medical assistance arrives.
- Conditions
- Healthy Subjects, Opioid Antagonist, Pharmacokinetics
- Trial name
- NCT04764630
- Testing
- Four naloxone nasal spray doses (1 every 2.5 min), Four naloxone nasal spray doses (2 every 2.5 min), Two naloxone nasal spray doses (1 every 2.5 min)
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Pharmacokinetic
A Pharmacokinetic Study of PLENVU® in Healthy Subjects
This study characterises the pharmacokinetic (PK) profile of the active ingredients of PLENVU (NER1006) and their related substances/metabolites. Subjects will receive PLENVU.
- Trial name
- PKPU (NCT03437265)
- Testing
- PLENVU powder for oral solution
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Norgine
Pharmacokinetics, Safety Issues
A Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab
The aim of the Clinical study is to evaluate the pharmacokinetic and safety profile of a new formulation of Bevacizumab (Zutrab®, Argentinian origin) when compared to two already marketed formulations of Bevacizumab Avastin®…
- Trial name
- NCT03919448
- Testing
- Bevacizumab
- Where
- Argentina
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
Pharmacokinetics, Safety
Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048
This is a proof of concept study to determine whether an extended release vaginal film can deliver drug for seven days. Two film formulations containing MK-2048 which differ by dissolution and spreadability attributes will be…
- Trial name
- FAME103 (NCT04319718)
- Testing
- MK-2048 High Eudragit Vaginal Film, MK-2048 Low Eudragit Vaginal Film
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Hillier, Sharon, PhD
Pharmacokinetics, Safety
JOTROL PK, Safety, and Food Effect Assessment
Type of Study: Single Ascending Doses (SAD) Study Objectives: To characterize the pharmacokinetic (PK) profile of JOTROL (resveratrol) following oral administration of SAD ranging from 200 mg up to a dose currently estimated at…
- Conditions
- Pharmacokinetics, Safety, Food-drug Interaction
- Trial name
- NCT04668274
- Testing
- 200 mg resveratrol as JOTROL, 500 mg resveratrol as JOTROL, 700 mg resveratrol as JOTROL
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Jupiter Orphan Therapeutics Inc.
Healthy Subjects, Drug-drug Interaction
A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants
This drug-drug interaction (DDI) study has been designed to investigate the effect of a moderate CYP3A inducer efavirenz on the pharmacokinetics of quizartinib and its major circulating active metabolite AC886.
- Conditions
- Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, Quizartinib
- Trial name
- NCT04459598
- Testing
- Efavirenz, Quizartinib
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo Co., Ltd.
ECG, Pharmacokinetics
Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML
This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory…
- Conditions
- ECG, Pharmacokinetics, Safety
- Trial name
- NCT03727750
- Testing
- Gemtuzumab Ozogamicin
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 51 people
- Sponsor
- Pfizer
Pharmacokinetic
A Study in Healthy Subjects to Evaluate Pharmacokinetics and Food Effect After Dosing of GS-248
The study will collect information about pharmacokinetics (PK), safety and tolerability following a single dose of GS-248 in two different oral solid formulations in capsules to healthy subjects.
- Trial name
- NCT04617509
- Testing
- Formulation A GS-248, Formulation B GS-248
- Where
- Sweden
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Gesynta Pharma AB
Pharmacokinetics, Beta Lactam Adverse Reaction
Beta-lactam Pharmacokinetics in Secondary Care
Currently in the UK, TDM is routinely performed for aminoglycosides and glycopeptide antimicrobial agents, given fears over the narrow therapeutic window of these agents and the serious adverse events associated with toxicity.
- Conditions
- Pharmacokinetics, Beta Lactam Adverse Reaction, Penicillin Allergy
- Trial name
- NCT03033394
- Testing
- Beta-lactam antibiotic
- Where
- United Kingdom
- Volunteers
- 65 people
- Sponsor
- Imperial College London
Modified Release Oral Formulation, Left Ventricular Systolic Dysfunction
COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure
The primary objectives of this study are (i) to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in adults with heart failure and left ventricular systolic…
- Conditions
- Modified Release Oral Formulation, Left Ventricular Systolic Dysfunction, Chronic Heart Failure, History of Chronic Heart Failure
- Trial name
- COSMIC-HF (NCT01786512)
- Testing
- Omecamtiv Mecarbil Matrix F1 Formulation, Omecamtiv Mecarbil Matrix F2 Formulation, Omecamtiv Mecarbil Swellable Core Technology F2
- Where
- 101 sites in United States, Australia and 11 more
- Volunteers
- 544 people
- Sponsor
- Cytokinetics
Ranitidine Adverse Reaction, Pharmacokinetics
Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration
Ranitidine is an over-the-counter and prescription drug, which decreases the amount of acid secreted by the stomach. Some ranitidine medicines contain an impurity called N-nitrosodimethylamine (NDMA) at low levels.
- Conditions
- Ranitidine Adverse Reaction, Pharmacokinetics, Food-drug Interaction
- Trial name
- NCT04397445
- Testing
- Ranitidine, Low nitrite/NDMA meals, High nitrite/NDMA meals
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Pharmacokinetics
Study to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil
The purpose of this study is to evaluate and compare the Pharmacokinetics (PK) of concomitant administration of Padsevonil (PSL) in the presence and absence of erythromycin in healthy study participants.
- Trial name
- NCT03480243
- Testing
- Padsevonil (UCB0942), Erythromycin
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
Healthy Subjects, Drug-drug Interaction
A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants
The purpose of this study is to investigate the one-way drug-drug interaction potential of quizartinib on dabigatran etexilate in healthy adult participants.
- Conditions
- Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, Quizartinib
- Trial name
- NCT04459585
- Testing
- Dabigatran Etexilate Mesylate, Quizartinib
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo Co., Ltd.