acute myeloid leukemia advanced solid tumors lymphoma
Conditions
Interventions
During the study the volunteer will receive ASTX660, quinidine (Group 1 only),
or fexofenadine (Group 2 only) after an overnight fast (at least 10 hours).
The volunteer will be given ASTX660, quinid
Sponsors
Astex Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Sex assigned at birth : male or female; females of nonchildbearing potential, or postmenopausal. 2. Age : 18 to 65 years, inclusive, at screening. 3. Body mass index (BMI) : 18.0 to 32.0 kg/m2, inclusive, at screening. 4. Weight : >=50 kg. 5. Status : healthy subjects.
Exclusion criteria
Exclusion criteria: 1. Employee of PRA or the Sponsor. 2. History of relevant drug and/or food allergies. 3. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 2 years prior to screening in the current study. 4. History or presence of atrioventricular block (any degree) or sick sinus syndrome. 5. Subjects with increased cardiac risk evaluation based on the following criteria: • Smoking (no more than 2 packs of cigarettes) in the last 6 months prior to admission, including use of nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, e-cigarettes, or inhalers), or positive cotinine test at screening (ie, cotinine value >500 ng/mL will be excluded). • Subjects with first-degree family history of ischemic cardiac event at a young age (male
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To determine the effect of P-glycoprotein (P-gp) inhibition by quinidine on pharmacokinetics (PK) of ASTX660 - To determine the effect of P-gp inhibition by ASTX660 on PK of fexofenadine | — |
Secondary
| Measure | Time frame |
|---|---|
| - To determine the safety and tolerability of ASTX660 following oral administration alone or in combination with quinidine, a P-gp probe inhibitor; or with fexofenadine, a P-gp probe substrate | — |
Countries
Netherlands
Outcome results
None listed