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Healthy Participants clinical trials

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NCT ID: NCT06397144 Not yet recruiting - Clinical trials for Healthy Participants

A Study on 2 Different Combination Tablets of Nirmatrelvir Plus Ritonavir to Compare Them With Marketed Paxlovid in Healthy Participants

Start date: February 14, 2025
Phase: Phase 1
Study type: Interventional

Medicines that may have different names or be made in different ways but have the same effect on the body are called bioequivalent. The purpose of this study is to learn about the bioequivalence of nirmatrelvir plus ritonavir after taking 2 different combination tablet forms by mouth. These combination tablets are compared to the tablet formulation that is already in the market. This study will be done under fasted conditions in healthy adult participants. This study is seeking participants who are: - Male and non-pregnant female participants aged 18 years and above. - with a body weight of more than 50 kilograms and Body Mass Index (BMI) between 16 to 32 kilograms per meter squared. - are healthy as confirmed by medical history, physical examination, laboratory tests. The study will also look at the safety and tolerability of nirmatrelvir plus ritonavir combination tablet and marketed tablet formulations in healthy adult participants. The study will consist of 4 treatments: Treatment A: Single oral dose of nirmatrelvir plus ritonavir 150 (1 × 150)/100 milligrams marketed tablets under fasted conditions (Reference 1) Treatment B (low dose strength): Single oral dose of nirmatrelvir plus ritonavir 150/100 milligrams (2 × [75/50 milligrams]) combination tablets under fasted conditions (Test 1) Treatment C: Single oral dose of nirmatrelvir/ritonavir 300 (2 × 150)/100 milligrams marketed tablets under fasted conditions (Reference 2) Treatment D (high dose strength): Single oral dose of nirmatrelvir/ritonavir 300/100 milligrams (2 × [150/50 milligrams]) combination tablets under fasted conditions (Test 2) All treatments will be given under fasted conditions. Fasted condition means the participants would not have had anything to eat before taking the medicines. Around 28 participants will be enrolled in the study. Healthy participants will be tested to see if they can be in the study within 28 days before receiving the study medicine. Selected participants will be admitted to the clinical research unit (CRU) one day before receiving the study medicine and will remain in the CRU until discharge after completing all the treatment periods. On Day 1 of each period, participants will be given a single dose of study medicine nirmatrelvir/ritonavir 300/100 mg or 150/100 mg by mouth by chance. Study medicine will be given with approximately 240 milliliters of room temperature water under fasted conditions (overnight fast of at least 10 hours and no food until 4 hours after receiving the study medicine). Blood samples will be collected at different times of the day up to 48 hours after taking the study medicine. Participants will be discharged from the CRU on Day 3 of Period 4, after all the study related procedures have been completed. A follow-up call will be made to participants around 28 to 35 days from receiving the final dose of the study medicine. The study will look at the experiences of participants receiving the study medicine. This will help to understand if the study medicine is safe and effective.

NCT ID: NCT06393517 Not yet recruiting - Clinical trials for Healthy Participants

A Study to Learn How Different Forms of the Study Medicine Called PF-06954522 Are Taken up Into the Blood in Healthy Adults

Start date: April 30, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare three finished products of PF-06954522 in terms of the uptake into the blood stream. This study is seeking participants who are: - Healthy male or female participants aged 18 years or older. All participants in this study will receive PF-06954522 once by mouth. The participants may receive different tablets by mouth for PF-06954522. The study will compare experiences of people receiving three different products of PF-06954522. This will help understand how much PF-06954522 is taken up into the blood for each product given. Participants will take part into the study for about 77 days. During this time participants will have to stay onsite for 21 days. There will be one follow up (by telephone) study visit.

NCT ID: NCT06392230 Not yet recruiting - Clinical trials for Healthy Participants

A Study to Learn How the Medicine Called [14C] PF-06821497 is Taken up Into and Removed From the Body.

Start date: May 24, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn how a certain amount of [14C] PF-06821497 is taken up into the bloodstream and removed from the body. The study is seeking participants who are: - Males aged 18 years or older. - Are confirmed to be healthy after performing some medical and physical tests. - Weigh more than 50 kilograms and have a body mass index of 16 to 32 kg per meter squared. The study consists of two parts. In part one, all participants will receive one full dose of [14C]PF-06821497 by mouth. Part two will begin at least 14 days after the dose in part one. In part two participants will receive one full dose of PF-06821497 by mouth and one small dose of [14C]PF-06821497 by intravenous (IV) infusion. IV infusion will be directly injected into the veins. To understand how the medicine is processed in the body, samples of blood, urine, and feces will be collected after each dose is given. This will help understand: - How much PF-06821497 is taken up into the bloodstream when taken by mouth compared to the dose given by IV - How the body removes it from the bloodstream. Participants will take part in the study for about 11 weeks, including the initial evaluation and follow-up periods.

NCT ID: NCT06368440 Not yet recruiting - Clinical trials for Healthy Participants

A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants

Start date: May 15, 2024
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants.

NCT ID: NCT06366243 Not yet recruiting - Clinical trials for Healthy Participants

A Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Emraclidine in Healthy Adult Participants

Start date: May 10, 2024
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the potential of gastric pH-dependent drug-drug interaction effect of esomeprazole, a proton pump inhibitor (PPI), on the pharmacokinetics (PK) of emraclidine in healthy adult participants.

NCT ID: NCT06342713 Not yet recruiting - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035

Start date: May 28, 2024
Phase: Phase 1
Study type: Interventional

This study is the first-in-human (FIH) study for BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants. Study details include: - The study duration will be up to 16 months. - The treatment duration will be up to 14 days. - Safety follow-up 30 days after last dose of study drug.

NCT ID: NCT06337110 Not yet recruiting - Clinical trials for Healthy Participants

A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men

Start date: April 5, 2024
Phase: Phase 1
Study type: Interventional

The main goal of this study is to learn about how Lu AF28996 moves into, through, and out of the body after a single dose is given to healthy male participants.

NCT ID: NCT06315335 Not yet recruiting - Clinical trials for Healthy Participants

A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants

Start date: July 2024
Phase: Phase 1
Study type: Interventional

The purpose of the study is investigate the safety, tolerability and pharmacokinetic of UCB9741 after 2 dose strengths administered subcutaneous as a single-dose in healthy Caucasian and Japanese participants.

NCT ID: NCT06310824 Not yet recruiting - Clinical trials for Healthy Participants

Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®

Start date: May 2024
Phase: Phase 1
Study type: Interventional

A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®

NCT ID: NCT06170723 Not yet recruiting - Clinical trials for Healthy Participants

A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants

Start date: March 15, 2024
Phase: Phase 1
Study type: Interventional

This 2-part study will evaluate the effect of coadministration of a Cytochrome P450, family 3, subfamily A (CYP3A) inhibitor, itraconazole (Part 1), and a high-fat/high-calorie meal and a modified gastric pH (Part 2), on the single dose drug levels of BMS-986368 in healthy participants.