Cocaine Use DisorderPhase 1NCT06648668
A Study to Investigate the Interaction Between TMP-301 and Cocaine.
A Phase 1 study testing TMP-301 in people with Cocaine Use Disorder, run by Tempero Bio, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- TMP-301
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2025to 5 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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:
- 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).
Who cannot join
- 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.
- 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.
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- 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.
- Are seropositive for hepatitis B surface antigen, hepatitis C antibody (asymptomatic hepatitis C virus infection at Screening is allowed), or human immunodeficiency virus (HIV).
- Have significant current suicidal ideation or a history of suicide attempt within the past 12 months, as assessed by the C-SSRS (baseline version), or have significant current homicidal ideation.
- If female, is currently pregnant (positive pregnancy test) or lactating, or who is planning to become pregnant within 30 days of last study drug administration.
- Use of a prohibited medication or investigational drug, as specified in protocol.
- Consumption of any foods or beverages that alter CYP1A2 activity (e.g., barbecued food or cruciferous vegetables, such as broccoli and cauliflower) or CYP3A4 activity (e.g., foods or beverages containing grapefruit or Seville-type oranges), within 7 days prior to admission to the Baseline Phase (a list of prohibited foods will be provided to participants).
- Have received blood products within 2 months of admission to the Baseline Phase.
- Positive UDS at admission to the Baseline Phase (Day -3), other than cocaine or tetrahydrocannabinol (THC). If THC is positive, a cannabis intoxication evaluation will be done by an investigator, and participants may be permitted to continue in the study at the discretion of an investigator. The UDS may be repeated and/or the participant may be rescheduled at the investigator's discretion.
- Have donated or lost more than 500 mL whole blood within 56 days or have donated plasma within 7 days prior to Screening, or have participated in another clinical trial within the last 30 days prior to screening.
- Have difficulty with venous access or are unsuitable or unwilling to undergo catheter insertion or direct venipuncture.
- Currently on probation or have any pending legal action that could prohibit participation or compliance in the study.
- Are an employee of the sponsor, a research site staff member directly affiliated with this study, or are an immediate family member, defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Have any other condition that, in an investigator's opinion, (i) puts participant at increased risk, (ii) could confound the study results, (iii) may interfere significantly with participant's participation in the study, or (iv) have the potential to limit the participant's ability to complete the study .
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral TMP-301 Given Concurrently With Cocaine
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.
Read the detailed description
This will be a randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, tolerability, PK, and PD of oral TMP-301, given concurrently with cocaine. The study will consist of 4 phases: Screening, Baseline, Treatment, and Follow-up. The Screening Phase will be completed as an outpatient visit within 24 days of the Baseline Phase and will consist of a standard medical screen. Within 24 days of a standard medical screening, eligible participants will return to the clinical site as inpatients to complete the Baseline Phase. All participants will remain in-clinic for the duration of the 7-day Treatment Phase. Following confirmation of eligibility, participants will be randomized to one of two treatment groups, either TMP-301 or. A safety follow-up visit will be conducted on Day 23.
- Conditions
- Cocaine Use Disorder
- Being tested
- TMP-301, Placebo
- Keywords
- CUD, Substance Use Disorder, SUD
- Medical subject headings
- Systemic carnitine deficiency, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMP-301Drug
Once daily [QD] × 14 days
PlaceboDrug
Once daily [QD] × 14 days
| Study group | Role | What they receive |
|---|---|---|
| TMP-301 | Experimental | Once daily [QD] × 14 days Receives: Drug: TMP-301 |
| Placebo | Placebo comparator | Once daily [QD] × 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of TMP-301 alone via incidence and severity of treatment-emergent adverse events (TEAEs) with cocaine infusions.
Measured: 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.
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of heart rate (CFBmax).
Measured: 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).
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of systolic blood pressure (SBP).
Measured: 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).
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of diastolic blood pressure (DBP).
Measured: 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).
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of quantitative electrocardiogram PR interval
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of quantitative electrocardiogram QRS complex.
Measured: 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.
Measured: 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.
Measured: Baseline to Day 23
Secondary outcomes (45)
To assess the maximum observed plasma concentration (Cmax) of cocaine alone.
Measured: Days 7 and 14
To assess the maximum observed plasma concentration (Cmax) of cocaine with TMP-301.
Measured: Days 7 and 14
To assess the Tmax of cocaine alone.
Measured: Days 7 and 14
To assess the Tmax of cocaine with TMP-301.
Measured: 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.
Measured: 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 with TMP-301.
Measured: Days 7 and 14
To assess the AUC from time 0 to infinity (AUC0-inf) of cocaine alone.
Measured: Days 7 and 14
To assess the AUC from time 0 to infinity (AUC0-inf) of cocaine alone in combination with TMP-301.
Measured: Days 7 and 14
To assess the elimination rate constant (λz) of cocaine alone.
Measured: Days 7 and 14
To assess the elimination rate constant (λz) of cocaine in combination with TMP-301.
Measured: Days 7 and 14
To assess the t1/2 of cocaine alone.
Measured: Days 7 and 14
To assess the t1/2 of cocaine in combination with TMP-301.
Measured: Days 7 and 14
To assess the apparent clearance (CL; if data permit) of cocaine alone.
Measured: Days 7 and 14
To assess the apparent clearance (CL; if data permit) of cocaine in combination with TMP-301.
Measured: Days 7 and 14
To assess the apparent volume of distribution (Vd; if data permit) of cocaine alone.
Measured: Days 7 and 14
To assess the apparent volume of distribution (Vd; if data permit) of cocaine in combination with TMP-301.
Measured: Days 7 and 14
To assess the metabolite-to-parent ratio (Cmax) of cocaine alone.
Measured: Days 7 and 14
To assess the metabolite-to-parent ratio (area under the plasma concentration versus time curve) of cocaine alone.
Measured: Days 7 and 14
To assess the metabolite-to-parent ratio (Cmax) of cocaine in combination with TMP-301.
Measured: Days 7 and 14
To assess the metabolite-to-parent ratio (area under the plasma concentration versus time curve) of cocaine in combination with TMP-301.
Measured: Days 7 and 14
To assess the visual analog scale (0-100): maximum effect (Emax) from time 0 to 60 minutes post-cocaine infusion of cocaine alone.
Higher score is worse
Measured: Days 7 and 14
To assess the visual analog scale (0-100): Area Under the Effect Curve (AUE) from time 0 to 60 minutes post-cocaine infusion of cocaine alone.
Higher score is worse
Measured: Days 7 and 14
To assess the visual analog scale (0-100): maximum effect (Emax) from time 0 to 60 minutes post-cocaine infusion of cocaine in combination with TMP-301.
Higher score is worse
Measured: Days 7 and 14
To assess the visual analog scale (0-100): AUE from time 0 to 60 minutes post-cocaine infusion of cocaine in combination with TMP-301.
Higher score is worse
Measured: Days 7 and 14
To assess the Brief Substance Craving Scale (BSCS) scores over time of cocaine alone.
The BSCS is a self-administered assessment that asks the participant to rate his or her craving for cocaine. The BSCS used for this study is a modification of the State of Feelings and Cravings Questionnaire.
Measured: Days 7 and 14
To assess the Brief Substance Craving Scale (BSCS) scores over time of cocaine in combination with TMP-301.
The BSCS is a self-administered assessment that asks the participant to rate his or her craving for cocaine. The BSCS used for this study is a modification of the State of Feelings and Cravings Questionnaire.
Measured: Days 7 and 14
To assess the Cmax of TMP-301.
Measured: Days 7 and 14
To assess the Tmax of TMP-301.
Measured: Days 7 and 14
To assess the AUC during a dosing interval (AUC0-τ) of TMP-301.
Measured: Days 7 and 14
To assess the λz of TMP-301.
Measured: Days 7 and 14
To assess the t1/2 of TMP-301.
Measured: Days 7 and 14
To assess the CL/F (if data permit) of TMP-301.
Measured: Days 7 and 14
To assess the Vd/F (if data permit) of TMP-301.
Measured: Days 7 and 14
To evaluate the safety and tolerability of TMP-301 as assessed by the incidence and severity of Treatments Emergent Adverse Events (TEAEs).
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by number of participants taking concomitant medications taken during study participation.
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by systolic blood pressure.
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by diastolic blood pressure.
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by heart rate.
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by electrocardiogram PR interval.
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by electrocardiogram QRS complex.
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by number of participants with abnormal laboratory test results.
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by Beck Depression Inventory (BDI) scores (0-63) over time.
Score of 63 is worse.
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by the Brief Psychiatric Rating Scale (BPRS) scores (0-126) over time.
Score of 126 is worse.
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by number of participants with abnormal physical examination findings.
Measured: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) score (0-5)
Score of 5 is worse.
Measured: Baseline to Day 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start4 Jan 2025
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel-group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tempero Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648668
- Sponsor's protocol ID
- TMP-301-CUD-102
- Status last verified
- May 2025
- First submitted
- 10 Oct 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral TMP-301 Given Concurrently With Cocaine
- ClinicalTrials.gov ID
- NCT06648668
- Acronym / sponsor ID
- TMP-301-CUD-102
- Conditions
- Cocaine Use Disorder
- Keywords
- CUD, Substance Use Disorder, SUD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Tempero Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2025 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, tolerability, PK, and PD of oral TMP-301, given concurrently with cocaine. The study will consist of 4 phases: Screening, Baseline, Treatment, and Follow-up. The Screening Phase will be completed as an outpatient visit within 24 days of the Baseline Phase and will consist of a standard medical screen. Within 24 days of a standard medical screening, eligible participants will return to the clinical site as inpatients to complete the Baseline Phase. All participants will remain in-clinic for the duration of the 7-day Treatment Phase. Following confirmation of eligibility, participants will be randomized to one of two treatment groups, either TMP-301 or. A safety follow-up visit will be conducted on Day 23.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel-group
| Arm | Type | Receives |
|---|---|---|
| TMP-301 | Experimental | Drug: TMP-301Once daily [QD] × 14 days |
| Placebo | Placebo comparator | Drug: PlaceboOnce daily [QD] × 14 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (28 listed)
- 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.
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMP-301Once daily [QD] × 14 days | Drug | TMP-301 |
| PlaceboOnce daily [QD] × 14 days | Drug | Placebo |
Primary outcome
To evaluate the safety and tolerability of TMP-301 alone via incidence and severity of treatment-emergent adverse events (TEAEs) with cocaine infusions.
Time frame: 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.
Time frame: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of heart rate (CFBmax).
Time frame: 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).
Time frame: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of systolic blood pressure (SBP).
Time frame: 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).
Time frame: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of diastolic blood pressure (DBP).
Time frame: 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).
Time frame: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of quantitative electrocardiogram PR interval
Time frame: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 alone via peak change from baseline of quantitative electrocardiogram QRS complex.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Day 23
45 secondary outcomes
To assess the maximum observed plasma concentration (Cmax) of cocaine alone.
Time frame: Days 7 and 14
To assess the maximum observed plasma concentration (Cmax) of cocaine with TMP-301.
Time frame: Days 7 and 14
To assess the Tmax of cocaine alone.
Time frame: Days 7 and 14
To assess the Tmax of cocaine with TMP-301.
Time frame: 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.
Time frame: 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 with TMP-301.
Time frame: Days 7 and 14
To assess the AUC from time 0 to infinity (AUC0-inf) of cocaine alone.
Time frame: Days 7 and 14
To assess the AUC from time 0 to infinity (AUC0-inf) of cocaine alone in combination with TMP-301.
Time frame: Days 7 and 14
To assess the elimination rate constant (λz) of cocaine alone.
Time frame: Days 7 and 14
To assess the elimination rate constant (λz) of cocaine in combination with TMP-301.
Time frame: Days 7 and 14
To assess the t1/2 of cocaine alone.
Time frame: Days 7 and 14
To assess the t1/2 of cocaine in combination with TMP-301.
Time frame: Days 7 and 14
To assess the apparent clearance (CL; if data permit) of cocaine alone.
Time frame: Days 7 and 14
To assess the apparent clearance (CL; if data permit) of cocaine in combination with TMP-301.
Time frame: Days 7 and 14
To assess the apparent volume of distribution (Vd; if data permit) of cocaine alone.
Time frame: Days 7 and 14
To assess the apparent volume of distribution (Vd; if data permit) of cocaine in combination with TMP-301.
Time frame: Days 7 and 14
To assess the metabolite-to-parent ratio (Cmax) of cocaine alone.
Time frame: Days 7 and 14
To assess the metabolite-to-parent ratio (area under the plasma concentration versus time curve) of cocaine alone.
Time frame: Days 7 and 14
To assess the metabolite-to-parent ratio (Cmax) of cocaine in combination with TMP-301.
Time frame: Days 7 and 14
To assess the metabolite-to-parent ratio (area under the plasma concentration versus time curve) of cocaine in combination with TMP-301.
Time frame: Days 7 and 14
To assess the visual analog scale (0-100): maximum effect (Emax) from time 0 to 60 minutes post-cocaine infusion of cocaine alone.
Time frame: Days 7 and 14
To assess the visual analog scale (0-100): Area Under the Effect Curve (AUE) from time 0 to 60 minutes post-cocaine infusion of cocaine alone.
Time frame: Days 7 and 14
To assess the visual analog scale (0-100): maximum effect (Emax) from time 0 to 60 minutes post-cocaine infusion of cocaine in combination with TMP-301.
Time frame: Days 7 and 14
To assess the visual analog scale (0-100): AUE from time 0 to 60 minutes post-cocaine infusion of cocaine in combination with TMP-301.
Time frame: Days 7 and 14
To assess the Brief Substance Craving Scale (BSCS) scores over time of cocaine alone.
Time frame: Days 7 and 14
To assess the Brief Substance Craving Scale (BSCS) scores over time of cocaine in combination with TMP-301.
Time frame: Days 7 and 14
To assess the Cmax of TMP-301.
Time frame: Days 7 and 14
To assess the Tmax of TMP-301.
Time frame: Days 7 and 14
To assess the AUC during a dosing interval (AUC0-τ) of TMP-301.
Time frame: Days 7 and 14
To assess the λz of TMP-301.
Time frame: Days 7 and 14
To assess the t1/2 of TMP-301.
Time frame: Days 7 and 14
To assess the CL/F (if data permit) of TMP-301.
Time frame: Days 7 and 14
To assess the Vd/F (if data permit) of TMP-301.
Time frame: Days 7 and 14
To evaluate the safety and tolerability of TMP-301 as assessed by the incidence and severity of Treatments Emergent Adverse Events (TEAEs).
Time frame: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by number of participants taking concomitant medications taken during study participation.
Time frame: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by systolic blood pressure.
Time frame: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by diastolic blood pressure.
Time frame: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by heart rate.
Time frame: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by electrocardiogram PR interval.
Time frame: Baseline to Day 23
To evaluate the safety and tolerability of TMP-301 as assessed by electrocardiogram QRS complex.
Time frame: Baseline to Day 23
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TMP-301 in people with Cocaine Use Disorder, run by Tempero Bio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of TMP-301 alone via incidence and severity of treatment-emergent adverse events (TEAEs) with cocaine infusions. (time frame: Baseline to Day 23). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.