Multiple Ascending Dose Study of TMP-301 in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT06025396|
Recruitment Status : Recruiting
First Posted : September 6, 2023
Last Update Posted : September 14, 2023
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Use Disorder Substance Use Disorders Healthy Volunteers||Drug: TMP-301 Drug: Placebo||Phase 1|
This study will be a randomized, double-blind, placebo controlled, fixed sequence, MAD study. The study will be conducted in a single clinical research unit (CRU). The study will consist of up to 4 cohorts. Subjects will only participate in 1 cohort.
Screening will occur within approximately 28 days prior to the first scheduled study drug administration. Subjects who meet all inclusion criteria and none of the exclusion criteria and who consent to participation will be admitted to the CRU for baseline evaluations prior to dosing.
Subjects will be fasted overnight for 10 hours prior to the morning dose, followed by a 2 hour fast. Subjects are fasted for 2 hours prior to dosing and 2 hours following the evening dose for the cohort 1 (50 mg bid).
Subjects will be discharged from the CRU on Day 18. Subjects will return to the CRU on Day 25 for a follow-up visit and EOS procedures.
Caffeine (100 mg) will be included as probe CYP1A2 substrate in cohort 2 and subsequent cohorts.
The maximum duration of subject participation, including Screening, will be approximately 53 days.
Subjects who terminate the study early will perform follow-up procedures at the time of Early Termination.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||sequential assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Double blind|
|Official Title:||A Phase 1, Randomized, Placebo-Controlled, Multiple Ascending Dose (MAD) Study To Evaluate The Safety, Tolerability, and Pharmacokinetics of TMP-301 in Healthy Subjects|
|Actual Study Start Date :||January 6, 2023|
|Estimated Primary Completion Date :||December 27, 2023|
|Estimated Study Completion Date :||December 27, 2023|
Experimental: Active TMP-301
Cohort 1= 50mg, capsules form, one capsule - two times per day - total 100mg/day;
Cohort 2= 50mg, capsule form, 1 capsules - one time per day- total 50mg/day
Cohort 3= 50mg, capsule form, 2 capsules - one time per day- total 100mg/day;
Cohort 4 = Dose Titration: 50mg, capsule form, 1 capsules - one time per day - total 50 mg/day - on Days 1-7; and 50 mg, capsule form, 2 capsules - one time per day - total 100mg/day - on Days 8-14;
Each cohort duration is 14 days of dosing
Multiple ascending dose active
Placebo Comparator: Placebo
Cohort 1= Placebo, capsules form, one capsule - two times per day;
Cohort 2= Placebo, capsule form, 1 capsules - one time per day;
Cohort 3= Placebo, capsule form, 2 capsules - one time per day;
Cohort 4 = Dose Titration: Placebo, capsule form, 1 capsules - one time per day - on Days 1-7; and Placebo, capsule form, 2 capsules - one time per day - on Days 8-14;
Each cohort duration is 14 days of dosing
Multiple ascending dose comparator
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Within each cohort from screening to end of the follow up period up to 25 days ]Occurence of Adverse Events, spontaneously reported and identified through clinical laboratory tests, vital sign measurements, ECG, physical exams and psychiatric assessments.
- Plasma levels TMP 301 [ Time Frame: Within each cohort from screening to end of the follow up period up to 25 days ]Repeated collections on Day 1, intermittent samples from Day 2 through Day 13, repeated collections on Day 14, and intermittent samples during washout
- Caffeine and paraxanthine concentration as a marker of CYP1A2 activity [ Time Frame: Within each cohort, from Pre-dose levels at Day -1 to Day 14. ]Caffeine and paraxanthine concentration
- Presence of TMP-301 or metabolites in Urine [ Time Frame: Within each cohort, urine will be collected on Day 1 (0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 12 - 24 hours) and Day 14 (0 to 4 hours, 4 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 48 hours (Day 15), and 48 - 72 hours (Day 16)). ]Identification of metabolites, if any, detected in urine samples.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06025396
|Contact: Dan Meyers, MDfirstname.lastname@example.org|
|Contact: Chris Resburgemail@example.com|
|United States, Kansas|
|Overland Park, Kansas, United States, 66212|
|Contact: Debra Kelsh, MD 913-696-1601 firstname.lastname@example.org|
|Study Director:||Dan Meyers, MD||CMO, Tempero Bio|