Study in healthy volunteers of the safety and how the body handles PCN-101

Phase 1

Completed

• Conditions: Depression; Mental Health - Depression

• Registration Number: ACTRN12620000226909
• Lead Sponsor: PERCEPTION NEUROSCIENCE, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-24
• Study Completion: 2020-08-08
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Inclusion Criteria:

• Able and willing to provide signed and dated informed consent
• BMI within the range of 18 to 30, weighing between 50 kg and 100 kg
• Healthy as determined by medical history, physical examination, and clinical laboratory evaluations
• Male subjects must be sterile for at least 6 months or agree to use a double barrier method of contraception
• Female subjects of child-bearing potential must be practicing a highly effective birth control
• Female subjects of non-childbearing potential must be either surgically sterile or post-menopausal
• Has a haemoglobin value of > 120 g/L at Screening

Exclusion Criteria

Exclusion Criteria:
•Pregnant or breast-feeding female
• Has a primary diagnosis of current (active) generalised anxiety disorder, panic disorder, obsessive compulsive disorder, post traumatic stress disorder, anorexia nervosa, or bulimia nervosa
• Has an active psychotic disorder within 10 years of Baseline
• Is taking compound(s) known to induce or inhibit cytochrome P450 oxidase (CYP) drug metabolising enzymes
• Has clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Baseline
• Has hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg) or any history of a hypertensive crisis
• Has an abnormal ECG of clinical relevance at Screening or Baseline
• Has past history of seizures
• Has received an investigational drug or participated in a clinical trial within 30 days of Screening
• Has a drug or alcohol abuse disorder within the past 5 years prior to Baseline or there is reason to believe a subject has such a history
• Has smoked tobacco, used tobacco or nicotine products (including e-cigarettes) in the past 6 months prior to Baseline

Study & Design

• Study Type: Interventional
• Study Design: Not specified