PET measurement of hepatobiliary transport of Telmisartan in a therapeutic dose using [11C]Telmisartan in normal subjects as a determinant of nonlinear pharmacokinetics.

PET measurement of hepatobiliary transport of Telmisartan in a therapeutic dose using [11C]Telmisartan in normal subjects as a determinant of nonlinear pharmacokinetics. - Pharmacokinetics of [11C]Telmisartan under oral therapeutic dose in healthy volunteers (TEL-1B).

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007715

Enrollment

Registered

2012-04-10

Start date

2012-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy male subjects

Interventions

To inject [11C]Ttelmisartan intravenously for PET imaging in baseline and under oral administration of a single therapeutic dose of Telmisartan.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Normal subjects with body weight >= 50kg and <85kg, and body mass index >= 17.6 and <26.4.

Exclusion criteria

Exclusion criteria: 1. Renal artery stenosis, bilaterally or unilaterally after nephrectomy 2. Hyperkalemia 3. Liver or renal dysfunction 4. Cerebrovascular disorders 5. Hypotension 6. Severe bradycardia, or WPW or LGL syndrome by ECG 7. Medication or dietary supplement including St. John's wort within 7 days prior to PET study

Design outcomes

Primary

Measure	Time frame
Plasma concentration time course and hepatobiliary pharmacokinetics of [11C]telmisartan.	—

Countries

Japan

Contacts

Public ContactYutaka Kaede

Foundation for Biomedical Research and Innovation Ethics and Safety Section, Audit Dept.

rinri@fbri.org078-306-0798

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026