A Study to Investigate the Interaction Between TMP-301 and Cocaine.

NCT06648668 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: TMP-301-CUD-102
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine Use Disorder

Keywords

CUD, Substance Use Disorder, SUD

Outcome Measures

Primary Outcomes (12)

• To evaluate the safety and tolerability of TMP-301 alone via incidence and severity of treatment-emergent adverse events (TEAEs) with cocaine infusions.

  Baseline to Day 23

• 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.

  Baseline to Day 23

• To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of heart rate (CFBmax).

  Baseline to Day 23

• To evaluate the safety and tolerability of TMP-301 in combination with cocaine via peak change from baseline of heart rate (CFBmax).

  Baseline to Day 23

• To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of systolic blood pressure (SBP).

  Baseline to Day 23

• To evaluate the safety and tolerability of TMP-301 in combination with cocaine via peak change from baseline of systolic blood pressure (SBP).

  Baseline to Day 23

• To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of diastolic blood pressure (DBP).

  Baseline to Day 23

• To evaluate the safety and tolerability of TMP-301 in combination with cocaine via peak change from baseline of diastolic blood pressure (DBP).

  Baseline to Day 23

• To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of quantitative electrocardiogram PR interval

  Baseline to Day 23

• To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of quantitative electrocardiogram QRS complex.

  Baseline to Day 23

• To evaluate the safety and tolerability of TMP-301 in combination with cocaine via peak change from baseline of quantitative electrocardiogram PR interval.

  Baseline to Day 23

• To evaluate the safety and tolerability of TMP-301 in combination with cocaine via peak change from baseline of quantitative electrocardiogram QRS complex.

  Baseline to Day 23

Secondary Outcomes (45)

• To assess the maximum observed plasma concentration (Cmax) of cocaine alone.

  Days 7 and 14

• To assess the maximum observed plasma concentration (Cmax) of cocaine with TMP-301.

  Days 7 and 14

• To assess the Tmax of cocaine alone.

  Days 7 and 14

• To assess the Tmax of cocaine with TMP-301.

  Days 7 and 14

• To assess the area under the plasma concentration-time curve from time 0 to the last measured concentration (AUC0-t) of cocaine alone.

  Days 7 and 14

Study Arms (2)

TMP-301

EXPERIMENTAL

Once daily \[QD\] × 14 days

Drug: TMP-301

Placebo

PLACEBO COMPARATOR

Once daily \[QD\] × 14 days

Drug: Placebo

Interventions

TMP-301 DRUG

Once daily \[QD\] × 14 days

TMP-301

Placebo DRUG

Once daily \[QD\] × 14 days

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• DBP: 50 to 89 mmHg, inclusive
• HR: 45 to 99 bpm, inclusive
• If male, agree to use a double-barrier method (e.g., condom and spermicide) or agree to remain abstinent from heterosexual intercourse at the time of Screening, during the study, and for 90 days following the last administration of study drug. Male participants must agree not to donate sperm during the study and for 90 days following the last administration of study drug.
• If female, meets one of the following criteria:
• a. Physiological postmenopausal status, defined as the following: i. Absence of menses for at least 12 months prior to the first study drug administration (without an alternative medical condition); OR b. Surgically sterile (e.g., have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation/occlusion).

You may not qualify if:

• 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.
• 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.
• Have a family history of significant mental, behavioral, or neurodevelopmental disorders, unless determined by the investigator to be not clinically significant (NCS).
• Have a current or past history of seizures, including alcohol- or stimulant-related seizures (excluding childhood febrile seizures), or significant family history of idiopathic seizure disorder or clinically significant (CS) head injury.
• Have a diagnosis of adult (i.e., 21 years or older) asthma, or chronic obstructive pulmonary disease (COPD), including those with a history of acute asthma within the past two years, and those with current or recent (past 2 years) treatment with inhaled or oral beta-agonist.
• Smoked \>40 cigarettes per day on average, in the month prior to Screening, or are unable to abstain from smoking (or use of any nicotine-containing substance) for at least 8 hours.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by an investigator.
• History of stomach or intestinal surgery, or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
• Evidence of CS hepatic or renal impairment, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine \>1.5 × the upper limit of normal (ULN) at Screening or admission to the Baseline Phase. Retesting may be permitted at the discretion of an investigator.
• Any clinically significant abnormalities in laboratory test results at Screening that would, in the opinion of an investigator, increase the participant's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data. Retesting may be permitted at the discretion of an investigator.

Sponsors & Collaborators

• Tempero Bio, Inc.: lead

Study Sites (1)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Systemic carnitine deficiency; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel-group

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 18, 2024
• Study Start: January 4, 2025
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)