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Pharmacokinetics clinical trials

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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.

NCT ID: NCT02068105 Completed - Pharmacokinetics Clinical Trials

A Study of ALKS 5461 in Healthy Volunteers

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

This is a study to test the safety of ALKS 5461 in healthy adults.

NCT ID: NCT02059343 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)

Start date: March 2014
Phase: N/A
Study type: Observational

Dexmedetomidine is increasingly used for sedation in children placed on cardiopulmonary bypass for heart surgery. It is also often used after surgery and may be particularly helpful for children with heart disease. In order for this medication to be helpful and to minimize risks associated with taking the medication, it is important to provide correct dosing for this medication. Based on evidence from studies of other medications used during heart surgery, it is likely that dosing of dexmedetomidine while on cardiopulmonary bypass is different from dosing in other settings. The purpose of this study is to evaluate how the heart-lung bypass machine affects dexmedetomidine levels in the body.

NCT ID: NCT02054754 Completed - Cancer Clinical Trials

Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects

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

The purpose of this study is to test the safety and observe the pharmacokinetics (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy male subjects following a single oral dose.