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NCT04667013

A Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of TBN

StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved 3 years later.

See at-risk trials from Guangzhou Magpie Pharmaceuticals Co., Ltd.

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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Mar 31, 2026 to Mar 31, 2029
    • Start date: Sep 1, 2025 to Sep 1, 2028
    • Study completion pushed from Aug 30, 2026 to Aug 30, 2029
    v7
  2. Primary completion date: Jun 30, 2025 to Mar 31, 2026
    • Start date: Dec 15, 2024 to Sep 1, 2025
    • Eligibility criteria expanded, about 8 words
    • Study completion date: Aug 30, 2025 to Aug 30, 2026
    v6
  3. Primary completion date: Jun 30, 2024 to Jun 30, 2025
    • Start date: Dec 15, 2023 to Dec 15, 2024
    • Study completion date: Aug 30, 2024 to Aug 30, 2025
    v5
  4. Primary completion date: Jun 30, 2023 to Jun 30, 2024
    • Start date: Dec 15, 2022 to Dec 15, 2023
    • Study completion date: Aug 30, 2023 to Aug 30, 2024
    v4
  5. Primary completion date: Apr 30, 2022 to Jun 30, 2023
    • Start date: Jan 15, 2022 to Dec 15, 2022
    • Study completion date: Jul 30, 2022 to Aug 30, 2023
    v3
  6. Primary completion date: Aug 30, 2021 to Apr 30, 2022
    • Start date: Feb 21, 2021 to Jan 15, 2022
    • Study completion date: Oct 30, 2021 to Jul 30, 2022
    v2
  7. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Number of participants with Adverse Events (AEs)
Timeframe: 14 days
Assessment of physical examination.
Timeframe: 14 days
Assessment of vital signs.
Timeframe: 14 days
Assessment of 12 lead-ECG.
Timeframe: 14 days
Assessment of urine pregnancy.
Timeframe: 14 days
Assessment of Clinical Laboratory Tests.
Timeframe: 14 days

Secondary (11)

Maximum observed concentration (Cmax) of TBN and its metabolite.
Time of occurrence of Cmax (Tmax) of TBN and its metabolite.
Area under the concentration-time curve from time zero to time 12 hours (AUC0-12) of TBN and its metabolite.
Lowest concentration before the next dose is administered (Ctrough) of TBN and its metabolite.
Area under the concentration-time curve for one dosing interval (12 hours) at steady-state (AUC0-tau) of TBN and its metabolite.
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Average drug concentration calculated at AUC0-tau/tau (Caverage) of TBN and its metabolite.
Minimum observed concentration at steady-state (Cmin_ss) of TBN and its metabolite.
Area under the concentration-time curve from time zero to the 24 hours concentration (AUC0-24) of TBN and its metabolite.
Maximum observed concentration at steady-state (Cmax_ss) of TBN and its metabolite.
Time of observed Cmax_ss (Tmax_ss) of TBN and its metabolite.
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of TBN and its metabolite.

Arms and interventions

Cohort 1Experimental

2 x 300 mg TBN tablets for a total dose of 600 mg or 2 matching placebo tablets (given approximately every 12 hours) for 6.5 consecutive days, until the morning dose of Day 7.

Cohort 2Experimental

4 x 300 mg TBN tablets for a total dose of 1200 mg or 4 matching placebo tablets (given approximately every 12 hours) for 6.5 consecutive days, until the morning dose of Day 7.

Drugs: Tetramethylpyrazine nitrone (TBN) tablet / Placebo