Safety, tolerability, pharmacokinetics (PK),... — Clinical Trial Details

Participants

Ages

25 – 65

Sexes

Male & Female

BMI

18 - 33.9

Psychosis History

Excluded

Inclusion Criteria

1. Participant has a body mass index (BMI) of 18 to 33.9 kg/m², inclusive.
2. Participant has not been administered any Monoamine Oxidase (MAO) inhibitor class antidepressants for at least 3 months prior to Screening.
3. Registered with a GP in the UK.
4. Sufficient intelligence to understand the nature of the trial and any hazards of participation in it. Ability to communicate satisfactorily with the Investigator and therapist team to participate in, and comply with the requirements of, the entire trial.
5. Healthy as determined by a responsible physician, based on no clinically significant findings from medical evaluation including medical history, a physical examination, concomitant medication, vital signs, 12-lead ECG and clinical laboratory evaluations (including haematology, coagulation, biochemistry and urinalysis) at the Screening visit and admission.
6. Agree to follow the contraception requirements of the trial.
7. Willing to be contacted by email and telephone and video call.
8. Proficient in reading and writing English sufficient to complete questionnaires.
9. Willing to give written consent to have data entered into The Over-volunteering Prevention System.
10. Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form, after having the opportunity to discuss the trial with the Investigator or their delegate.
Part A – Cohorts 1 and 2 Only
1. Healthy participants aged 25 to 65 years, inclusive.
2. Healthy psychedelic-experienced participants (defined in protocol).
3. No psychedelic drug use 6 weeks prior to dosing (excluding the study drug) until the end of the study.
Part A – Cohorts 3, 4 and 5 Only
1. Healthy participants aged 25 to 65 years, inclusive.
2. Healthy participants with little to no psychedelic experience (defined in protocol).
3. No psychedelic drug use 6 months prior to dosing (excluding the study drug) until the end of the study.

Exclusion Criteria

Psychiatric Exclusion Criteria:
1. DSM-5 substance use disorder as assessed by MINI or positive urine drugs of abuse (excluding cannabis within 24 hours).
2. Current or clinically relevant history of a psychotic disorder (including schizophrenia, psychosis, bipolar disorder, schizoaffective disorder, borderline personality disorder, etc.).
3. First-degree relatives with a clinically relevant history of a psychotic disorder.
4. Significant history of mania.
5. Psychiatric condition incompatible with rapport with the therapy team and/or safe exposure to DMT.
6. Significant suicide risk (see details).
General Medical Exclusion Criteria:
1. Clinically relevant abnormal physical or mental health interfering with the study.
2. Clinically relevant abnormal laboratory results, ECG or vital signs at Screening or Day -1.
3. Any acute condition or infection or chronic illness posing unacceptable risk.
4. Significant cardiovascular history or family history of long QT or sudden death.
5. AST, ALT, GGT or total bilirubin >1×ULN (with specified exceptions).
6. Neurological conditions associated with seizures.
7. Blood pressure or heart rate outside specified ranges at Screening.
8. QTcF ≥450 msec (males) or ≥470 msec (females) at Screening or predose on Day 1.
9. Clinically significant ECG abnormalities.
10. Positive test for HBsAg, anti-HCV or anti-HIV I/II at Screening.
11. Intake of >21 units alcohol weekly or inability to refrain from alcohol.
12. Receipt of an investigational product in another trial within 3 months prior to Day -1.
13. Use of prescription or OTC medications (except hormonal contraception/HRT) within 28 days unless assessed case-by-case.
14. Current use of long-term prescription medicine deemed to pose interaction risk.
15. History of severe adverse reaction to any drug or sensitivity to serotonergic psychedelics.
16. POCBP who are pregnant, lactating or planning to conceive or not using reliable contraception; required negative pregnancy tests.
17. Blood/plasma donation >400 mL within 3 months prior to dosing.
18. Phobia of needles or blood.
19. Unsuitable veins for venepuncture and/or cannulation.
20. Unlikely to cooperate with study requirements.

Company

Product

Legal

Safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and effects of intravenous (IV) and intramuscular (IM) dosing of SPL028 (deuterated DMT fumarate [a serotonergic psychedelic]) in healthy volunteers and participants with major depressive disorder (MDD)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

SPL028

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details