A Study to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-906 in Healthy Participants


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Primary Outcome Measures:

  • Cmax: Maximum Observed Plasma Concentration for TAK-906 on Day 1 of First Intervention Period [ Time Frame: Day 1: Pre-dose and at multiple time points (up to 48 hours) post-dose of First Intervention Period ]
  • AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 on Day 1 of First Intervention Period [ Time Frame: Day 1: Pre-dose and at multiple time points (up to 48 hours) post-dose of First Intervention Period ]
  • AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-906 on Day 1 of First Intervention Period [ Time Frame: Day 1: Pre-dose and at multiple time points (up to 48 hours) post-dose of First Intervention Period ]
  • Cmax: Maximum Observed Plasma Concentration for TAK-906 on Day 4 of Second Intervention Period [ Time Frame: Day 4: Pre-dose and at multiple time points (up to 48 hours) post-dose of Second Intervention Period ]
  • AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 on Day 4 of Second Intervention Period [ Time Frame: Day 4: Pre-dose and at multiple time points (up to 48 hours) post-dose of Second Intervention Period ]
  • AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-906 on Day 4 of Second Intervention Period [ Time Frame: Day 4: Pre-dose and at multiple time points (up to 48 hours) post-dose of Second Intervention Period ]

The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy participants in order to evaluate the effect of the potent CYP3A4 inhibitor itraconazole on the single-dose PK of TAK-906 maleate.

The study will enroll approximately 12 participants. Participants will receive the following treatment sequence:

• TAK-906 maleate 25 mg; Itraconazole 200 mg + TAK-906 maleate 25 mg

Participants will be given an oral dose of TAK-906 in the First Intervention Period which will be followed by a washout period, after which participants will be given Itraconazole solution along with TAK-906 orally in the Second Intervention Period.

This single center trial will be conducted in the United States. The overall duration to participate in this study is 7 to 8 weeks. Participants will remain confined in the clinic from Day 1 up to Day 2 (First Intervention Period) and Day 4 up Day 6 (Second Intervention Period). Participants will return for a Follow-up Visit, 10 to 14 days after last dose of study drug.