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Research Article

Effects of CYP3A4 Inhibition/Induction and OATP Inhibition on the Pharmacokinetics of Atogepant in Healthy Adults

ORCID Icon, , &
Pages 445-456 | Received 24 May 2023, Accepted 08 Aug 2023, Published online: 31 Aug 2023

Figures & data

Figure 1. Study design for study A and B. Black bar indicates confinement days.

*Dosing occurred after 10 h fast.

Figure 1. Study design for study A and B. Black bar indicates confinement days.*Dosing occurred after 10 h fast.

Table 1. Participant characteristics.

Figure 2. Study A: the mean plasma atogepant concentration–time profiles following oral administration of 60 mg atogepant alone or in presence of steady-state itraconazole.

(A) Linear scale, (B) semilogarithmic plot. Error bars represent standard deviation.

Figure 2. Study A: the mean plasma atogepant concentration–time profiles following oral administration of 60 mg atogepant alone or in presence of steady-state itraconazole. (A) Linear scale, (B) semilogarithmic plot. Error bars represent standard deviation.

Table 2. Pharmacokinetic parameters of atogepant following administration with and without itraconazole in healthy participants; Study A (N = 40).

Figure 3. Study B: mean plasma atogepant concentration–time profiles following oral administration of 60 mg atogepant alone or in combination with single-dose 600 mg rifampin.

(A) Linear scale, (B) semilogarithmic plot. Error bars represent standard deviation.

Figure 3. Study B: mean plasma atogepant concentration–time profiles following oral administration of 60 mg atogepant alone or in combination with single-dose 600 mg rifampin. (A) Linear scale, (B) semilogarithmic plot. Error bars represent standard deviation.
Figure 4. Study B: mean plasma atogepant concentration–time profiles following oral administration of atogepant 60 mg alone or in combination with multidose rifampin 600 mg.

(A) Linear scale, (B) semilogarithmic plot. Error bars represent standard deviation.

Figure 4. Study B: mean plasma atogepant concentration–time profiles following oral administration of atogepant 60 mg alone or in combination with multidose rifampin 600 mg. (A) Linear scale, (B) semilogarithmic plot. Error bars represent standard deviation.

Table 3. Pharmacokinetic parameters of atogepant following administration with and without rifampin in healthy participants; study B (N = 31).

Table 4. Number (%) of participants with treatment-emergent adverse events (TEAE) by study treatment, system organ class and preferred term (safety population).

Data sharing statement

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (e.g., protocols and Clinical Study Reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

This clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: https://www.abbvieclinicaltrials.com/hcp/data-sharing/