Mass Balance Study of [¹⁴C]Purinostat Mesylate for Injection in Healthy Participants

ConditionMB
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorChengdu Zenitar Biomedical Technology Co., Ltd

About this trial

This trial adopts a single-center, open-label, non-randomized, single-dose study design. It is planned to enroll 6 healthy Chinese male participants, and the final standard is to collect complete samples and data to be tested from at least 6 participants.

After each participant receives a single intravenous infusion of 19 mg (approximately 50 μCi) of \[¹⁴C\] Purinostat Mesylate for Injection on the first day of the trial, whole blood, plasma, urine and feces samples will be collected at specified time points/time periods during the trial. By measuring the total radioactivity, the whole blood-to-plasma ratio of total radioactivity, the pharmacokinetic parameters of total, recovery rate and excretion route data of the total radioactivity in whole blood (if applicable) and plasma.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 19 mg /50 μCi of [¹⁴C] Purinostat Mesylate

    Drug

    Participants received a single intravenous infusion of \[14C\]Purinostat Mesylate under fasting conditions. The dose was set at the clinically proposed standard dosage (approximately 19 mg per person, administered once, with a radioactive activity of 50 μCi).

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Purinostat MesylateExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative excretion rate of total radioactivity in urine and feces

Time frame
Through 216 hours postdose

Secondary outcomes

1

Cmax

Time frame
Through 120 hours postdose
2

Tmax

Time frame
Through 120 hours postdose
3

AUC0-t

Time frame
Through 120 hours postdose
4

t1/2

Time frame
Through 120 hours postdose

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: