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Pharmacokinetics clinical trials

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NCT ID: NCT02169804 Completed - Pharmacokinetics Clinical Trials

An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal

Start date: August 2014
Phase: Phase 1
Study type: Interventional

• To determine and compare the pharmacokinetics (PK) of 3 doses of 25 mg Androxal in elderly healthy adult male subjects.

NCT ID: NCT02169713 Completed - Healthy Subjects Clinical Trials

Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects

Start date: May 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of solifenacin and mirabegron on the concentrations of tamsulosin HCl after combined dosing. This study will also evaluate the safety and tolerability of the combined administration of solifenacin, mirabegron and tamsulosin HCl.

NCT ID: NCT02147392 Completed - Pharmacokinetics Clinical Trials

Assessment of [11C]ER176 to Image Translocator Protein in Brain and Whole Body of Healthy People

Start date: May 14, 2014
Phase: Early Phase 1
Study type: Interventional

Background: - A protein called translocator protein may play a role in brain inflammation. Sometimes it is present at higher levels in the lungs than in the brain. Researchers want to see if a drug called [11C]ER176 can provide an image of this protein in the brain. Objective: - To test the ability of a drug to image a protein, and test how it is distributed in the body. Eligibility: - Healthy adults over age 18. Design: - Participants will be screened with medical history, physical exam, and blood and urine tests. - Participants will have a PET scan of the brain using [11C]ER176. It will be injected through an intravenous tube into 1-2 arm veins. A tube may also be put into an artery at the wrist or elbow. Some participants will also have a lung scan. - For the PET, participants will lie on a bed that slides in and out of a doughnut-shaped scanner. A plastic mask will be molded to their face and head. They may be wrapped with restraining sheets. The scan will last about 120 minutes. Blood may be taken during the scan. - Blood and urine will be taken before and after the scan. - During another visit, participants will have an MRI scan of the brain. Participants will lie on a table that slides in and out of a metal cylinder. A strong magnetic field and radio waves will take pictures of the brain. The scanner makes loud knocking noises. Participants will be given earplugs. - Some participants will have only a whole-body PET scan using [11C]ER176.

NCT ID: NCT02127034 Completed - Healthy Subjects Clinical Trials

Study to Evaluate the Effect of Solifenacin and Mirabegron on the Digoxin Concentrations in Blood in Healthy Subjects

Start date: March 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of steady state solifenacin and mirabegron on the pharmacokinetics of co-administered steady state digoxin. This study will also evaluate the safety and tolerability of the combined steady state administration of solifenacin, mirabegron and digoxin.

NCT ID: NCT02126956 Completed - Pharmacokinetics Clinical Trials

Mass Balance, Pharmacokinetics, and Metabolism of 14C-labeled ACT-128800 Administered to Healthy Male Subjects

Start date: March 2009
Phase: Phase 1
Study type: Interventional

The study was conducted to investigate the metabolism and mass balance of ACT-128800, and to identify the elimination pathways (metabolism and excretion) of ACT-128800 and compare them with the known metabolic profiles of ACT-128800 in animals.

NCT ID: NCT02117869 Completed - Pharmacokinetics Clinical Trials

The Effect of Low Furanocoumarin Grapefruit Hybrid Juice Consumption on Midazolam Pharmacokinetics

Start date: May 2014
Phase: Phase 4
Study type: Interventional

Grapefruit (GF) contains furanocoumarin (FC) which is known to irreversibly inhibit the activity of cytochrome P450-3A (CYP3A) enzymes in the human gastrointestinal tract (PAINE 2005). Because CYP3A enzymes are integral in the metabolism of some drugs, co-ingesting GF or GF Juice (GFJ), which inhibits CYP3A, along with drugs reliant on CYP3A for metabolism can significantly alter the drugs kinetic properties and result in elevated plasma drug concentrations which may be toxic. The Citrus Research and Education Center at the University of Florida has developed a new GF hybrid (GFH) which contains low FC content and which may not inhibit CYP3A enzyme activity, and therefore may be safe to co-ingest with drugs that require CYP3A activity for metabolism. The investigators hypothesize that low FC GFHJ will not inhibit CYP3A to the degree that regular GFJ does, and will not significantly affect midazolam kinetics compared with regular GFJ. Midazolam is an FDA approved probe drug for CYP3A activity and has been used previously to establish an interaction between GFJ and midazolam. This study will evaluate the concomitant administration of midazolam and low FC GFHJ, regular GFJ, or water to evaluate the significance of this interaction.

NCT ID: NCT02107885 Completed - Pharmacokinetics Clinical Trials

Single Ascending Dose Study Using DS-1971 to Assess Safety, Tolerability, and Pharmacokinetics in Healthy Participants.

Start date: March 2014
Phase: Phase 1
Study type: Interventional

This is a randomised, double-blind, placebo-controlled and ascending single dose study. It is hypothesised that single oral doses of DS-1971a within the planned dose range will be safe and well tolerated by healthy male subjects.

NCT ID: NCT02097953 Completed - Pharmacokinetics Clinical Trials

Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin

Start date: May 2014
Phase: Phase 0
Study type: Interventional

The purpose of this study is to understand how an antibiotic, rifampin, may change the blood levels of another antibiotic, daptomycin, in the body. In addition, the effect of polymorphisms in P-glycoprotein (a protein involved in the removal of daptomycin from the body) on the blood levels of daptomycin will be evaluated. The hypotheses are that rifampin will decrease the blood levels of daptomycin and that the effect will be greater for certain P-glycoprotein polymorphisms.

NCT ID: NCT02092571 Completed - Pharmacokinetics Clinical Trials

A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal Women

Start date: February 2014
Phase: Phase 1
Study type: Interventional

A study to assess the pharmacokinetics of 2 progesterone vaginal rings in postmenopausal women

NCT ID: NCT02085863 Completed - Pharmacokinetics Clinical Trials

A Phase I Study in Young Healthy Women to Investigate the Effects of Laquinimod on Standard Oral Contraceptive When Both Treatments Are Given Together

Start date: February 2014
Phase: Phase 1
Study type: Interventional

This is a single center, randomized, double blind, placebo controlled, 2-way crossover drug-drug interaction (DDI) study to assess the effect of laquinimod on the PK and PD of ethinylestradiol (EE) and levonorgestrel (LNG) a commonly used oral contraceptive combination.