A Phase 1 Trial to Assess the Mass Balance, Absolute Bioavailability, and Pharmacokinetics of 14C ASTX660 in Healthy Volunteers

A Phase 1 Trial to Assess the Mass Balance, Absolute Bioavailability, and Pharmacokinetics of 14C ASTX660 in Healthy Volunteers - Mass Balance and Pharmacokinetics of 14C-ASTX660 in Healthy Volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49455

Enrollment

Registered

2020-04-21

Start date

2020-09-22

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

solid tumors, lymphoma advanced solid tumors lymphoma

Interventions

ASTX660 will be given as an oral capsule with 240 milliliters (mL) of tap water and an intravenous infusion (solution of the compound that will be administered directly in a blood vessel). On Day 1

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Gender: Male or female Age: 18 to 65 years, inclusive, at screening Body mass index: 18.0 to 30.0 kg/m2, inclusive at screening

Exclusion criteria

Exclusion criteria: 1. Employee of PRA or the Sponsor. 2. History of significant drug and/or food allergies. 3. Using alcohol in the 48 hours (2 days) prior to screening and each admission to the clinical research center is not allowed. 4. Using tobacco products in the 3 months prior to screening. 5. Known significant mental illness or other condition, such as active alcohol, or other substance abuse or addiction, that in the opinion of the Investigator predisposes the subject to high risk of noncompliance with the protocol. 6. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and each admission to the clinical research center. See the protocol for the complete overview

Design outcomes

Primary

Measure	Time frame
To identify and quantify the main excretion pathways of ASTX660, including the mass balance of excretion in urine and feces.	—

Secondary

Measure	Time frame
To determine the oral absolute bioavailability (F) of ASTX660 after single dose administration in the fasted condition. To determine the fraction of ASTX660 dose absorbed (Fa). To determine the PK of ASTX660 following oral and IV administration. To determine the safety and tolerability of ASTX660 following oral and IV administration. To identify the metabolites of ASTX660 in plasma, urine, and feces, if feasible.	—

Measure

Time frame

To determine the oral absolute bioavailability (F) of ASTX660 after single dose administration in the fasted condition. To determine the fraction of ASTX660 dose absorbed (Fa). To determine the PK of ASTX660 following oral and IV administration. To determine the safety and tolerability of ASTX660 following oral and IV administration. To identify the metabolites of ASTX660 in plasma, urine, and feces, if feasible.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)