NCT06768944 - Stress Experience Following Psilocybin | Biotech Hunter

Enrollment

36

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

October 31, 2027

Conditions

Assessing the Importance of Cortisol in Facilitating Positive Outcomes Induced by Psilocybin in Healthy Participants

Interventions

DRUG

Psilocybin 25 mg

The drug product (DP) PEX010 is a capsule for oral administration and is manufactured with DS PYEX (12.5-14.0% psilocybin), excipients, and HPMC capsules. The product is manufactured in two product strengths, and this represents the high-dose (25mg)

DRUG

Psilocybin 1 mg

The drug product (DP) PEX010 is a capsule for oral administration and is manufactured with DS PYEX (12.5-14.0% psilocybin), excipients, and HPMC capsules. The product is manufactured in two product strengths, and this represents the low-dose (1mg)

DRUG

Metyrapone 750 mg

metyrapone 750mg capsules, which will be administered in 2 doses

DRUG

Placebo

inactive placebo

Trial Locations (1)

T2N 4N1

University of Calgary, Calgary