Phase 1
Completed N=12
A Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole on the Single-dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT03849690 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for TAK-906 — 19.76; 17.24 nanogram per milliliter (ng/mL) — p=0.3011
Summary
The purpose of this study is to evaluate the effect of the proton pump inhibitor (PPI) esomeprazole 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 |
19.76; 17.24 | 0.3011 |
| PRIMARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 |
43.31; 37.98 | 0.0865 |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 |
44.03; 38.85 | 0.3011 |
| SECONDARY Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs |
2; 1; 3; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in Vital Signs |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline Clinical Laboratory Values |
0; 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.
- Has a body mass index (BMI) greater than or equal to (>=) 18 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.
- 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.
- Participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30 day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Study Period 1 of the current study.
Data sourced from ClinicalTrials.gov (NCT03849690). 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.