CS-3150 midazolam DDI study

An open-label, single-sequence crossover study to evaluate the effects of CS-3150 on the pharmacokinetics of midazolam in Japanese healthy subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222780

Enrollment

Registered

2015-03-04

Start date

2015-03-18

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 volunteers

Interventions

investigational material(s) Generic name etc : CS-3150 INN of investigational material : - Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational material : 1

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Male Japanese 2. Between the age of 20 and 45 3. Between the BMI of 18.5 and 24.9 4. Sitting blood pressure : systolic blood pressure < 140 mmHg, and diastolic blood pressure < 90 mmHg 5. Pulse rate <=99 bpm

Exclusion criteria

Exclusion criteria: 1. Presence or history of hypersensitivity or idiosyncratic reaction (penicillin allergy etc.) to a drug including midazolam. 2. Presence or history of drug or alcohol dependence. etc.

Design outcomes

Primary

Measure	Time frame
pharmacokinetics The PK parameters of midazolam	—

Secondary

Measure	Time frame
safety pharmacokinetics 1. Other PK parameters of free form and metabolites of midazolam 2. The PK parameters of CS-3150 3. Safety	—

Countries

Japan

Outcome results

None listed

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