Mass Balance Study of [14C]DA-302168S in Healthy Chinese Adult Male Participants

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorChendu DIAO Pharmaceutical Group CO., LTD.

About this trial

In this study, a single dose of \[14C\] radiolabelled DA-302168S will be administered orally. The main purpose of this study is to find out how much of DA-302168S and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral \[14C\] DA-302168S.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or MEN2; or serum calcitonin ≥50 ng/L at screening.

Trial design

Design model

Single group

Treatments tested in this trial

  • [14C] DA-302168S

    Drug

    Administered orally

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: [14C] DA-302168SExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total recovery of HDM1002 radioactivity in urine and feces, following oral administration of [14C] DA-302168S

Time frame
Predose up to Day 8 after administration of [14C]DA-302168S
2

Identification of Major Metabolites in Human Plasma, Urine, and Feces

Time frame
Predose up to Day 8 after administration of [14C]DA-302168S

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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