CompletedPhase 1

Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M

United Kingdom7 participantsStarted 2013-11

Plain-language summary

An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and Excretion of Radio Labeled SPN-810M in Healthy Adult Male Volunteers

Who can participate

Age range30 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Entry: 1. Healthy males. 2. Aged 30 to 55 years. 3. Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, urinalysis, vital signs, and electrocardiogram. 4. Able to voluntarily provide written informed consent to participate in the study.

What they're measuring

Urinary and fecal recoveries (mass balance) of total radioactivity.

Timeframe: 10 days post dose.

Trial details

NCT IDNCT02023606

SponsorSupernus Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-12

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