Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers

Usona Institute54 enrolled

Overview

The primary objective of the study is to assess the pharmacokinetics, safety, and tolerability of a single-dose and multiple-doses of 5-MeO-DMT administered by intramuscular (IM) injections in healthy subjects.

This study is a phase 1, first-in-human, double-blind, placebo-controlled, randomized, single-dose and multiple-ascending-dose study of 5-MeO-DMT administered by intramuscular injection in 54 healthy subjects (adult male and/or females, 18-65 years of age). Subjects will be randomized 6:1 to receive 5-MeO-DMT or placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Pharmacokinetics Safety Tolerability

Interventions

5-methoxy-N,N-dimethyltryptamine succinate saltDRUG

The 5-MeO-DMT drug product is comprised of the appropriate concentration of 5-MeO-DMT succinate salt drug substance in solution with 0.9% sodium chloride injection solution (USP) in a 5 mL glass vial, and is administered intramuscularly.

PlaceboDRUG

The placebo is commercially available 0.9% sodium chloride solution (USP) for injection. The placebo is provided by the pharmacy in single-use sterile syringes of the appropriate dose.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adult male or female. * Aged at least 18 years but not older than 65 years, inclusive. * Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2, inclusive. Exclusion Criteria: * History of significant hypersensitivity to the IP or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs. * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, or endocrine disorders, as determined by the investigator (or designee). * Participants who, in the opinion of the investigator (or designee), should not participate in this study. * Participant is participating in another study with a medical device or IP within the last 30 days prior to first study drug administration.

Locations (1)

Altasciences Clinical Kansas, Inc

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Number of participants with Treatment Emergent Adverse Events as coded by MedDRA and assessed by CTCAE v4.0

Number of participants with TEAEs following administration of 5-MeO-DMT.

Time frame: Up to 30 Days

Secondary Outcomes

Plasma pharmacokinetic parameters of 5-MeO-DMT and bufotenine following a single-dose and multiple-doses of 5-MeO-DMT

For PK analysis, blood samples will be collected before and up to 24 hours after the intramuscular administration of 5-MeO-DMT to determine 5-MeO-DMT and bufotenine serum concentrations.

Time frame: Up to 24 hours

Urine pharmacokinetic parameters of 5-MeO-DMT and bufotenine following a single-dose and multiple-doses of 5-MeO-DMT

For PK analysis, urine samples will be collected before and up to 24 hours after the intramuscular administration of 5-MeO-DMT to determine 5-MeO-DMT and bufotenine urine concentrations.

Time frame: Up to 24 hours

Data from ClinicalTrials.gov

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