NCT04121078

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

Completed Phase 1 Results posted Last updated 9 December 2020

What this trial tests

Phase 1 trial testing TAK-906 in Healthy Volunteers in 12 participants. Completed in 16 November 2019.

Timeline

15 October 2019

Primary endpoint
4 November 2019

16 November 2019

Quick facts

Lead sponsor	Millennium Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	12
Start date	15 October 2019
Primary completion	4 November 2019
Estimated completion	16 November 2019
Sites	1 location across United States

Drugs / interventions tested

• TAK-906
• Rifampin — full drug profile →

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Millennium Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 19 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cmax: Maximum Observed Plasma Concentration for TAK-906 Primary · Day 1: time zero and at multiple time points (up to 48 hours) post dose

Group	Value	95% CI
Treatment A: TAK-906 25 mg	14.37	± 38.7
Treatment B: Rifampin 600 mg and TAK-906 25 mg	89.62	± 68.6

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 Primary · Day 1: time zero and at multiple time points (up to 48 hours) post dose

Group	Value	95% CI
Treatment A: TAK-906 25 mg	32.68	± 23.9
Treatment B: Rifampin 600 mg and TAK-906 25 mg	168.5	± 49.9

AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 Primary · Day 1: time zero and at multiple time points (up to 48 hours) post dose

Group	Value	95% CI
Treatment A: TAK-906 25 mg	32.32	± 23.8
Treatment B: Rifampin 600 mg and TAK-906 25 mg	168.3	± 49.9

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) Secondary · Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)

Group	Value	95% CI
Treatment A: TAK-906 25 mg	6
Treatment B: Rifampin 600 mg and TAK-906 25 mg	2

Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values Secondary · Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)

Group	Value	95% CI
Treatment A: TAK-906 25 mg	0
Treatment B: Rifampin 600 mg and TAK-906 25 mg	0

Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings Secondary · Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)

Group	Value	95% CI
Treatment A: TAK-906 25 mg	0
Treatment B: Rifampin 600 mg and TAK-906 25 mg	0

Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values Secondary · Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)

Group	Value	95% CI
Treatment A: TAK-906 25 mg	0
Treatment B: Rifampin 600 mg and TAK-906 25 mg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (up to Day 23). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment A: TAK-906 25 mg

Serious: 0/12 (0%)

Deaths: 0/12

Treatment B: Rifampin 600 mg and TAK-906 25 mg

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (8 terms — click to expand)

Reaction	System	Treatment A: TAK-906 25 mg	Treatment B: Rifampin 600 …
Headache	Nervous system disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Sensory disturbance	Nervous system disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Sinus congestion	Respiratory, thoracic and mediastinal disorders	—	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT04121078 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The pharmacokinetics of oral trazpiroben (TAK-906) after organic anion transporting polypeptide 1B1/1B3 inhibition: A phase I, randomized study.
   Mukker JK, Dukes G, Tolkoff M, Wang L, et al · · 2022 · cited 6× · PMID 35460165 · DOI 10.1111/cts.13274