Clinical Trials Logo
  1. Home
  2. Celiac Disease
  3. NCT04604795

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GSK3915393 in Healthy Participants and to Evaluate the Interaction Between GSK3915393 and Grapefruit Juice and Itraconazole

Celiac Disease Clinical Trial

Official title:
A Randomized, Placebo Controlled, Double Blind, Single and Repeat Dose Escalation Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of GSK3915393 in Healthy Participants and Open Label Assessment of Coadministration of GSK3915393 With Grapefruit Juice and Itraconazole on the Pharmacokinetics of GSK3915393

Clinical Trial Summary

This is a 3-part first time into human study (FTIH) study for GSK3915393. Parts A and B of the study will evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending and repeat oral doses of GSK3915393 in healthy adult participants. Part C will evaluate the impact of co-administration of GSK3915393 with grapefruit juice and itraconazole on the PK of GSK3915393.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04604795
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date November 4, 2020
Completion date June 29, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT04349904 - Near-Focus NBI Classification of Villous Atrophy in Suspected Coeliac Disease: International Development and Validation
Recruiting NCT05581628 - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Completed NCT04593251 - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis Phase 1
Completed NCT05810441 - Intestinal Transglutaminase Antibodies in Celiac Disease Diagnosis
Recruiting NCT05555446 - Bovine Colostrum to Prevent Absorption of Gluten Early Phase 1
Completed NCT02754609 - Hookworm Therapy for Coeliac Disease Phase 1
Terminated NCT01902368 - Celiac Disease Screening N/A
Completed NCT02472704 - Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo N/A
Completed NCT02312349 - Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
Completed NCT01172665 - Celiac Disease Database
Completed NCT01100099 - HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease Phase 2/Phase 3
Completed NCT00639444 - Risk of Celiac Disease and Age at Gluten Introduction N/A
Active, not recruiting NCT05425446 - Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients Phase 1
Enrolling by invitation NCT02202681 - Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule N/A
Completed NCT00362856 - Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects Phase 2
Terminated NCT03866538 - Budesonide in Patients With Immune Mediated Enteropathies Phase 4
Recruiting NCT05135923 - Glutenfree, Gut Microbiota and Metabolic Regulation N/A
Completed NCT05052164 - Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women N/A
Completed NCT03775499 - Probiotic BL NCC 2705 and Gluten Sensitivity N/A
Completed NCT03707730 - A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease Phase 2