A Study to Investigate the Interaction Between TMP-301 and Cocaine. (NCT06648668) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Interaction Between TMP-301 and Cocaine.
United States18 participantsStarted 2025-01-04
Plain-language summary
This will be a randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral TMP-301, given concurrently with cocaine. The study will consist of 4 phases: Screening, Baseline, Treatment, and Follow-up.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Males and females between 18 and 55 years of age, inclusive.
✓. Understand the study procedures, follow instructions, and provide written informed consent.
✓. Have a body mass index (BMI) within a range of 18.0 to 34.0 kg/m2 and body weight ≥50.0 kg at Screening.
✓. Healthy, as determined by no clinically significant medical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory results (including hematology, clinical chemistry, urinalysis, and serology) at Screening, as judged by the investigator.
✓. ≥6 uses of cocaine by the smoked or IV route in the 12 months prior to Screening
✓. Provide a positive urine drug screen (UDS) for cocaine at least once during the screening period or at admission. Repeat or rescheduled testing will be allowed at the investigator's discretion.
✓. Have BP and Heart Rate (HR) within the following ranges after 5 minutes' rest at Screening and admission:
✓. SBP: 90 to 139 mmHg, inclusive
Exclusion criteria
✕. Meet current Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for any SUDs other than cocaine, cannabis, or nicotine. Diagnosis of mild to moderate alcohol use disorder will not be considered exclusionary.
✕. Have a DSM-5 psychiatric disorder other than SUD, including but not limited to, Bipolar Disorder, Major Depressive Disorder, or Schizophrenia, or have a neurological disorder requiring ongoing treatment and/or making study participation unsafe.
What they're measuring
1
To evaluate the safety and tolerability of TMP-301 alone via incidence and severity of treatment-emergent adverse events (TEAEs) with cocaine infusions.
Timeframe: Baseline to Day 23
2
To evaluate the safety and tolerability of TMP-301 in combination with cocaine via incidence and severity of treatment-emergent adverse events (TEAEs) with cocaine infusions.
Timeframe: Baseline to Day 23
3
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of heart rate (CFBmax).
Timeframe: Baseline to Day 23
4
To evaluate the safety and tolerability of TMP-301 in combination with cocaine via peak change from baseline of heart rate (CFBmax).
Timeframe: Baseline to Day 23
5
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of systolic blood pressure (SBP).
Timeframe: Baseline to Day 23
6
To evaluate the safety and tolerability of TMP-301 in combination with cocaine via peak change from baseline of systolic blood pressure (SBP).
Timeframe: Baseline to Day 23
7
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of diastolic blood pressure (DBP).
✕. Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, paranoid reaction, or epileptic seizure.
✕. Have a 12-lead ECG with repeated demonstration of corrected QT interval (QTcF) ≥470 msec in female participants or ≥450 msec in male participants at Screening.
✕. Unable to tolerate a 20 mg cocaine IV infusion (Day -2) or a 40 mg cocaine IV infusion (Day -1) during the Baseline Phase, as judged by the investigator or designee and per criteria in protocol;
✕. History or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, gastrointestinal, neurological, respiratory, or endocrine disorder, which would preclude safe or successful completion of the study, as determined by an investigator.
✕. Have a history of any illness, or a family history of early significant cardiovascular disease that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the participant.
✕. Have a significant risk of developing psychosis (assessed by Prevention through Risk Identification, Management, and Education \[PRIME\] screen) or have a personal history of psychotic symptoms (hallucinations or delusions), with or without a formal psychiatric diagnosis.
Timeframe: Baseline to Day 23
8
To evaluate the safety and tolerability of TMP-301 in combination with cocaine via peak change from baseline of diastolic blood pressure (DBP).
Timeframe: Baseline to Day 23
9
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of quantitative electrocardiogram PR interval
Timeframe: Baseline to Day 23
10
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of quantitative electrocardiogram QRS complex.
Timeframe: Baseline to Day 23
11
To evaluate the safety and tolerability of TMP-301 in combination with cocaine via peak change from baseline of quantitative electrocardiogram PR interval.
Timeframe: Baseline to Day 23
12
To evaluate the safety and tolerability of TMP-301 in combination with cocaine via peak change from baseline of quantitative electrocardiogram QRS complex.