Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers

Status Completed

Clinical Trial Summary

This is a Phase 1, single-dose, open-label, randomized, three-period, three-way crossover study in which healthy adult participants will receive three separate single-dose administrations of ASTX660 capsules under three different conditions.

Clinical Trial Description

Participants receiving Treatment A (fasting) will be dosed after having fasted overnight for at least 10 hours. Participants receiving Treatment B (fed; high-fat/high-calorie meal) will fast overnight for at least 10 hours then consume a Food and Drug Administration (FDA) standard high-fat, high-calorie breakfast beginning 30 minutes before dosing. Participants receiving Treatment C (fed; low-fat/low-calorie meal) will fast overnight for at least 10 hours then consume an FDA standard low-fat, low-calorie breakfast beginning 30 minutes before dosing. The duration of the study is expected to be approximately 47 days. ;

Study Design

Related Conditions & MeSH terms

Healthy Volunteer

Clinical Trial Details

NCT number	NCT04479800
Study type	Interventional
Source	Astex Pharmaceuticals, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	July 20, 2020
Completion date	August 25, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06326723` - Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects	Phase 1
Recruiting	`NCT00001367` - Diagnosis and History Study of Patients With Different Neurological Conditions
Completed	`NCT02699710` - Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects	Phase 1
Completed	`NCT02231892` - Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study	N/A
Not yet recruiting	`NCT06441916` - Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions	Phase 1
Completed	`NCT03771586` - A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects	Phase 1
Not yet recruiting	`NCT06337422` - Bioequivalence Study of Generic Celecoxib 200 mg Capsules	Phase 1
Completed	`NCT03302182` - Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects	Phase 1
Completed	`NCT05049343` - Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants	Phase 1
Recruiting	`NCT01629108` - Normal Values in Hearing and Balance Testing
Completed	`NCT02947854` - Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant	Phase 1
Completed	`NCT02534870` - Pharmacokinetics and Safety of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects	Phase 1
Completed	`NCT02224053` - Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers	Phase 1
Completed	`NCT01676584` - A Study of Single Dose RO6811135 in Healthy Volunteers	Phase 1
Completed	`NCT01697436` - A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets	Phase 1
Completed	`NCT01711762` - A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers	Phase 1
Completed	`NCT01684891` - A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers	Phase 1
Completed	`NCT01591850` - A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers	Phase 1
Completed	`NCT01414881` - Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects	Phase 1
Completed	`NCT01461967` - A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers	Phase 1