Clinical Trials Logo
  1. Home
  2. Leishmaniasis
  3. NCT04504435

Safety, Tolerability and Pharmacokinetics (PK) Investigation of GSK3494245 in Healthy Participants

Leishmaniasis Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, First Time in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single (in Both Fed and Fasted States) Doses of GSK3494245 in Healthy Participants

Clinical Trial Summary

This is a Phase 1, double-blind, randomized, placebo-controlled, first time in human (FTIH) study to assess the safety, tolerability and PK of a single dose of GSK3494245. The study will consist of 3 cohorts, conducted in a sequential manner. Cohorts 1 and 2 will consist of a single ascending dose (SAD), crossover design where each participant will receive a maximum of 3 ascending oral doses of GSK3494245 and 1 placebo dose under fasted conditions. At each dose level, GSK3494245 and placebo will be administered in a 3:1 ratio, within each period, according to the randomization schedule in a blinded manner. Cohort 3 will comprise of a 2-way crossover which includes 1 dosing regimen under fasted then fed conditions and 1 regimen under fed then fasted conditions in a 1:1 ratio. The fed conditions will investigate the effect of safety, tolerability and PK of a single dose of GSK3494245 following food administration.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04504435
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date September 29, 2020
Completion date January 11, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT03641339 - Defining Skin Immunity of a Bite of Key Insect Vectors in Humans N/A
Completed NCT00004755 - Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil Phase 2
Completed NCT00657618 - Use of Sodium Stibogluconate as a Treatment for Leishmaniasis Phase 1/Phase 2
Completed NCT04512742 - A Clinical Study to Develop a Controlled Human Infection Model Using Leishmania Major-infected Sand Flies N/A
Recruiting NCT00344188 - Diagnosis and Treatment of Leishmania Infections
Active, not recruiting NCT03009422 - Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis. N/A
Recruiting NCT05449717 - Incidence of Relapse and Post-Kala-Azar Dermal Leishmaniasis in South Sudan
Recruiting NCT06307171 - Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers N/A
Completed NCT01751048 - LEISH-F3 + GLA-SE and the LEISH-F3 + MPL-SE Vaccine Phase 1
Terminated NCT06124144 - Safety and Drug Absorption of Orally Administered Oleylphosphocholine (OlPC) in Healthy Adults Phase 1
Completed NCT00662012 - Sodium Stibogluconate Treatment of Leishmaniasis Phase 2
Completed NCT03993093 - Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre
Recruiting NCT03784248 - Mediterranean Visceral Leishmaniasis With Leishmania Infantum
Withdrawn NCT02429505 - Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
Completed NCT01377974 - Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis Phase 2
Completed NCT02656797 - Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis Phase 2
Completed NCT01484548 - Phase 1 LEISH-F3 Vaccine Trial in Healthy Adult Volunteers Phase 1
Completed NCT01300975 - Intralesional Antimony for Bolivian Cutaneous Leishmaniasis Phase 2
Completed NCT03294161 - Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis Phase 2
Completed NCT00401349 - Expression of Mif Alleles in Individuals With Leishmaniasis