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Healthy Volunteers clinical trials

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NCT ID: NCT04903093 Completed - Healthy Volunteers Clinical Trials

A Study Evaluating Relative Bioavailability of an Oral Suspension of Abrocitinib and Effect of an Acid Reducing Agent on the Bioavailability of Abrocitinib and Assessing the Taste of Abrocitinib Oral Formulations.

Start date: June 4, 2021
Phase: Phase 1
Study type: Interventional

This study consists of 2 parts: Part A is to estimate the relative bioavailability of a single 200 mg dose of abrocitinib oral suspension (Test formulation) compared to the commercial abrocitinib tablet (200 mg) (Reference formulation). The effect of an acid-reducing agent on the pharmacokinetics of abrocitinib and its metabolites will also be evaluated by administering abrocitinib 200 mg commercial tablet with or without famotidine 40 mg, as an acid-reducing agent. Part B is to assess the taste and palatability of six different abrocitinib oral suspension formulations. Additionally, the safety and tolerability of abrocitinib tablet (in Part A) and abrocitinib oral suspension formulations (in Part B) will be assessed when given with or without famotidine 40 mg once daily.

NCT ID: NCT04901078 Completed - Opioid-use Disorder Clinical Trials

A Phase 1 Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers

KTX101
Start date: April 7, 2022
Phase: Phase 1
Study type: Interventional

The primary objectives of this study are to evaluate the safety and tolerability of KNX100 administered orally as a single and multiple ascending doses in healthy volunteers.

NCT ID: NCT04898101 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Effect of [14C]Acp-196 (Acalabrutinib) in Healthy Adult Participants

Start date: March 3, 2016
Phase: Phase 1
Study type: Interventional

This study is to determine the absolute bioavailability of oral acalabrutinib and intravenous (IV) PK of [14C]ACP-196.

NCT ID: NCT04892641 Completed - Healthy Volunteers Clinical Trials

Phase 1 Study of Epetraborole Tablets

Start date: June 10, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1b double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PK, and food effect of epetraborole tablets administered to healthy adult subjects for up to 28 days.

NCT ID: NCT04891406 Completed - Healthy Volunteers Clinical Trials

A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

This study is a randomised cross-over, open-label, confinement study conducted in 24 male or female snus and cigarette consumers. The study investigates 5 different nicotine containing products in a cross-over fashion. The study incorporates pharmacokinetics evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety evaluation. During the study participation, subjects come for two visits to the clinic, including a 5-day confinement period.

NCT ID: NCT04890561 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women

Start date: May 17, 2021
Phase: Phase 1
Study type: Interventional

The primary purpose of the study is to estimate the cumulative amount of lemborexant excreted in breast milk following a single dose administration of lemborexant 10 milligram (mg) to healthy lactating women and to estimate the relative infant dose (RID) expressed as a percent of the daily maternal dose.

NCT ID: NCT04889573 Completed - Healthy Volunteers Clinical Trials

Immunoglobulin Gene Rearrangement and Repair in Healthy Donors

R2IGH
Start date: July 7, 2021
Phase: N/A
Study type: Interventional

B-cells ensure humoral immune response against antigens (Ag) thanks to their receptor (BCR). V(D)J rearrangement, somatic hypermutation, immunoglobulin (Ig) class switch and locus suicide recombination are mutational/recombinational processes targeting Ig loci influencing BCR expression. Study of these events is essential for B cell function analysis. Our project will provide the normal reference values using high throughput sequencing-based protocols.

NCT ID: NCT04883333 Completed - Healthy Volunteers Clinical Trials

A Single and Multiple Ascending-dose Trial of LEO 153339 in Healthy Adults

Start date: May 17, 2021
Phase: Phase 1
Study type: Interventional

This is a first-in-human study in adult healthy participants consisting of two parts. In Part 1, participants will receive one dose of study drug (LEO 153339) or placebo; in Part 2, participants will receive multiple doses of study drug or placebo. The participants will stay in the clinic for 6 days (Part 1) or for 12 days (Part 2) to have the study doctor assess their safety and to investigate how quickly and to what extent LEO 153339 (and the breakdown product) is absorbed, transported, and eliminated from the body. The purpose is to assess the safety and tolerability of LEO 153339 when compared to a placebo with no active ingredient.

NCT ID: NCT04882631 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants

Start date: April 12, 2021
Phase: Phase 1
Study type: Interventional

This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days.

NCT ID: NCT04881955 Completed - Healthy Volunteer Clinical Trials

Study of the Absorption, Metabolism, and Excretion of [14C]-Ecopipam in Healthy Male Subjects

Start date: May 12, 2021
Phase: Phase 1
Study type: Interventional

Phase 1, single-center (United Kingdom), open-label, nonrandomized, single-dose study in healthy adult male subjects to assess the absorption, metabolism, and excretion of [14C]-Ecopipam in Healthy Male Subjects.