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Tolerability clinical trials

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NCT ID: NCT04691115 Completed - Safety Clinical Trials

Safety, Tolerability and Pharmacokinetics of AM1476 in Healthy Subjects

Start date: December 16, 2020
Phase: Phase 1
Study type: Interventional

This is a First in Human (FIH), double-blind, randomised, placebo-controlled study designed to evaluate safety, tolerability and PK of single and multiple ascending oral doses of AM1476 in healthy subjects.

NCT ID: NCT02512575 Completed - Clinical trials for Rheumatoid Arthritis

A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.

Start date: November 18, 2015
Phase: Phase 1
Study type: Interventional

This is a Phase I, first-in-human (FIH), randomized, single-blind, placebo-controlled, single ascending dose sequential group study in healthy male subjects. The objectives are to study the safety, tolerability, pharmacokinetics and effects on glucose homeostasis (pharmacodynamics) of AZD9567, an oral differentiated non-steroidal selective glucocorticoid receptor modulator (SGRM). The study will also assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of prednisolone 60 mg in comparison with high doses of AZD9567 and placebo.

NCT ID: NCT02484729 Completed - Healthy Subjects Clinical Trials

A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 After Single Ascending Doses to Healthy Males

Start date: July 2015
Phase: Phase 1
Study type: Interventional

This study will be a randomized, single-blind, placebo-controlled first-in-human study in healthy male subjects to assess the safety, tolerability and pharmacokinetics of single ascending doses of AZD9977. In Part B of this study the regional absorption of AZD9977 along the gastro-intestinal tract will be investigated using the IntelliCap® system in a non-randomized, open-label, fixed-sequence design. The study will be performed at a single study centre.

NCT ID: NCT02206204 Completed - Pharmacokinetics Clinical Trials

Study of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects

Start date: June 2012
Phase: Phase 1
Study type: Interventional

This is a single-center, double-blind, randomized, placebo- and positive-controlled, double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over comparison between moxifloxacin and placebo in healthy male and female subjects. The primary objective is to demonstrate that selexipag and its metabolite ACT-333679 do not have an effect on cardiac repolarization exceeding the threshold of regulatory concern, at two orally administered dose levels (800 and 1600 μg twice daily) in healthy male and female subjects. Moxifloxacin is included as a positive control.

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: NCT02082158 Completed - Comfort Clinical Trials

Assessment of Novel Respiratory Protective Devices in Healthcare

Start date: July 2014
Phase: N/A
Study type: Interventional

This VA-based study will obtain feedback from healthcare workers via validated survey instrument on the comfort and tolerability of wearing current models of N95 respirators and novel respirator designs currently in development. There will be 4 novel respirators and 1 commonly used respirator (not locally used) to compare to a locally used respirator, which is familiar to participants. Comparisons will be examined between each of the first 5 models with the locally used control using Dunnett's t-test.

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.

NCT ID: NCT01981928 Completed - Safety Clinical Trials

A Clinical Trial to Investigate Safety and Tolerability of ASP7962 in Healthy Humans

Start date: November 2013
Phase: Phase 1
Study type: Interventional

The purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolized (chemically broken down), distributed through the body and excreted. A further aim is to look at how this process is possibly altered by food by giving the study drug in the presence and absence of meals.

NCT ID: NCT01959685 Completed - Pharmacokinetics Clinical Trials

A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal

Start date: October 2013
Phase: Phase 1
Study type: Interventional

To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.

NCT ID: NCT01954589 Completed - Pharmacokinetics Clinical Trials

Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-462206

Start date: November 2011
Phase: Phase 1
Study type: Interventional

A study of ACT-462206 to evaluate the tolerability, safety, pharmacokinetics, and pharmacodynamic of ascending single doses of ACT-462206, a novel dual orexin receptor antagonist in healthy male subjects.