CompletedPhase 1

PK Study in Subjects With Severe Hepatic Impairment

Czechia, Hungary, Slovakia12 participantsStarted 2018-11-06

Plain-language summary

This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. postmenopausal for at least 1 year, confirmed by follicle-stimulating hormone assessment (\>40 mIU/mL), or
✓. surgically sterilised (hysterectomy, bilateral oophorectomy or salpingectomy), or
✓. congenital sterility. Female subjects of child-bearing potential must practice effective contraception (see Protocol body) from the Screening Visit or at least 2 weeks before IMP administration, until 30 days after IMP dosing. Male subject must practice effective contraception from the time of IMP dosing until 90 days after IMP dosing. Adhering to strict abstinence is considered an accepted contraceptive method.

Exclusion criteria

✕. who have a positive pregnancy test at Screening or on Day -1.
✕. who are pregnant, lactating or planning to become pregnant during the study.

What they're measuring

Pharmacokinetic Parameters of MCI-186: Peak Drug Concentration (Cmax)

Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)

Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞)

Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

Trial details

NCT IDNCT03664544

SponsorTanabe Pharma Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03-25

Results submitted2020-03-24

View on ClinicalTrials.gov More Severe Hepatic Impairment trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. postmenopausal for at least 1 year, confirmed by follicle-stimulating hormone assessment (\>40 mIU/mL), or
✓. surgically sterilised (hysterectomy, bilateral oophorectomy or salpingectomy), or
✓. congenital sterility. Female subjects of child-bearing potential must practice effective contraception (see Protocol body) from the Screening Visit or at least 2 weeks before IMP administration, until 30 days after IMP dosing. Male subject must practice effective contraception from the time of IMP dosing until 90 days after IMP dosing. Adhering to strict abstinence is considered an accepted contraceptive method.

Exclusion criteria

✕. who have a positive pregnancy test at Screening or on Day -1.
✕. who are pregnant, lactating or planning to become pregnant during the study.

What they're measuring

Pharmacokinetic Parameters of MCI-186: Peak Drug Concentration (Cmax)

Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)

Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞)

Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)