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Healthy Volunteers clinical trials

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NCT ID: NCT04559971 Completed - Healthy Volunteers Clinical Trials

A Phase 1 Study to Evaluate the Safety, Tolerability, PK and PD of SLN124 in Healthy Volunteers

Start date: September 3, 2020
Phase: Early Phase 1
Study type: Interventional

This study will evaluate the safety and tolerability of SLN124 in healthy volunteers.

NCT ID: NCT04557800 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers

Start date: November 16, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), multiple ascending dose (MAD), and 28-day safety study of orally administered DNL151 in healthy volunteers.

NCT ID: NCT04555733 Completed - Healthy Volunteer Clinical Trials

A Single and Multiple Dose Study of Lemborexant in Healthy Chinese Participants

Start date: October 26, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to assess the pharmacokinetics (PK) of lemborexant and metabolites (M4, M9, and M10) in plasma in healthy Chinese participants following single and multiple oral doses of lemborexant.

NCT ID: NCT04551677 Completed - Healthy Volunteers Clinical Trials

Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2020-2021 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively

Start date: September 16, 2020
Phase: Phase 4
Study type: Interventional

Primary Objective: To provide serum samples (collected from participants before vaccination [Blood Sample 1] and after final vaccination [Blood Sample 2]) to Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines. In addition, serum samples from adult participants may be further analyzed by the Sponsor to assess breadth of immune response induced by the study vaccines.

NCT ID: NCT04551534 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers

Start date: June 1, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study conducted in three parts.

NCT ID: NCT04551079 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics (PK) of Oral TAK-994 in an Acute Sleep Phase Delay Paradigm in Healthy Male Participants

Start date: September 23, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of TAK-994 and to determine the effect of TAK-994 (compared to placebo) on sleepiness, as measured by mean sleep latency on the maintenance of wakefulness Test (MWT), in an acute sleep phase delay paradigm in healthy participants.

NCT ID: NCT04550195 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants

Start date: September 17, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986337 in healthy participants and in healthy Japanese participants.

NCT ID: NCT04547361 Completed - Healthy Volunteers Clinical Trials

A Study to Assess the Safety and Tolerability of E2511 in Healthy Participants

Start date: September 14, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of E2511 following single ascending oral doses in healthy adult and elderly participants.

NCT ID: NCT04546347 Completed - Healthy Volunteers Clinical Trials

A Study to Assess the Rel Bioavailability, Food Effect and Absolute Bioavailability on the Pharmacokinetics of AZD9833

Start date: September 17, 2020
Phase: Phase 1
Study type: Interventional

AstraZeneca AB is developing the test medicine, AZD9833, for the potential treatment of oestrogen receptor (ER) positive breast cancer. ER-positive breast cancer is where the cancer cells grow in response to the hormone oestrogen. The study will try to identify and compare how much of the test medicine formulations (recipes) are taken up into the blood when given as a tablet, a solution and as an injection directly into the vein. The dose given directly into the vein will be radiolabelled, meaning that it contains a radioactive component in order to track where the drug is in the body. This study will also look at the effect of food when taking the test medicine in the form of the tablet. The test medicine safety and tolerability will also be assessed. This is a one-part study involving up to 32 healthy post-menopausal female volunteers aged 50 to 70. Volunteers will be randomly assigned to a group of up to 8, two groups will partake in four study periods and two groups will partake in three study periods. Volunteers will be admitted to the clinical unit on the day before dosing (Day -1) for each study period. On Day 1 of each study period, volunteers will receive either a single oral dose (tablet or solution) of AZD9833 or a single oral dose (tablet) of AZD9833 co-administered with a single radiolabelled IV dose of [14C]AZD9833, in either the fed or fasted state. There will be a minimum 7 day washout between periods. Volunteers will remain resident until 72 hours post dose (Day 4) of each study period. A follow-up phone call will take place 5 to 7 days post-final dose to ensure the ongoing wellbeing of the volunteers.

NCT ID: NCT04545944 Completed - Healthy Volunteers Clinical Trials

Evaluation of Effect of Vonoprazan on Midazolam Pharmacokinetics in Healthy Participants

Start date: September 15, 2020
Phase: Phase 1
Study type: Interventional

To determine the time-dependent inhibition potential of repeated doses of oral vonoprazan on the pharmacokinetics (PK) of a single oral dose of midazolam, a sensitive cytochrome P450 3A4 (CYP3A4) substrate, in healthy participants.