Phase 1
Completed N=12
A Study to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of Organic Anion Transporting Polypeptide (OATP) 1B1 and OATP1B3 on the Single-Dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT04121078 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for TAK-906 — 14.37; 89.62 nanogram per milliliter (ng/mL)
Summary
The purpose of this study is to evaluate the effect of single dose intravenous rifampin on the single-dose PK of orally administered TAK-906.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for TAK-906 |
14.37; 89.62 | — |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 |
32.68; 168.5 | — |
| PRIMARY AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 |
32.32; 168.3 | — |
| SECONDARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) |
6; 2 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study, based on screening urine cotinine test.
- Body Mass Index (BMI) greater than or equal to (>=) 18.0 and less than or equal to ( 450 millisecond (msec) or ECG findings are deemed abnormal with clinical significance by the investigator or designee at screening.
- Estimated creatinine clearance <90 milliliter per minute (mL/min) at screening.
- Has been on a diet incompatible with the on-study diet, in the opinion of the investigator or designee, within the 30 days prior to the first dosing and throughout the study.
- Donation of blood or significant blood loss (example, approximately 500 milliliter [mL]) within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
Data sourced from ClinicalTrials.gov (NCT04121078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.