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

Completed

Conditions: solid tumors, lymphoma
advanced solid tumors
lymphoma
10024324

Registration Number: NL-OMON49455

Lead Sponsor: Astex Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 8

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To identify and quantify the main excretion pathways of ASTX660, including the<br /><br>mass balance of excretion in urine and feces.</p><br>

Secondary Outcome Measures

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