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A Single and Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics SCH 900931 in Healthy Adult Japanese Subjects.

A Single and Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics SCH 900931 in Healthy Adult Japanese Subjects.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000568910
Enrollment
24
Registered
2011-06-02
Start date
2011-07-04
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Interventions

Mode of Administration will be oral capsule. Part 1- Cohort 1: Rising single dose SCH900931 (Period 1:20mg, Period 2:100mg & Period 3:550mg). The duration of each Period will be 6 days, in between doses for Part 1 will be at least 7 days between Period 1 and Period 2 and at least 21 days between Period 2 and Period 3. Part 2- Cohort 2 & 3 : Rising multiple dose SCH900931 of 2 cohort in a parallel study design (Cohort 2: 150mg & Cohort 3:250mg). For Part 2, dosing will be once daily for 14 co

Mode of Administration will be oral capsule. Part 1- Cohort 1: Rising single dose SCH900931 (Period 1:20mg, Period 2:100mg & Period 3:550mg). The duration of each Period will be 6 days, in between doses for Part 1 will be at least 7 days between Period 1 and Period 2 and at least 21 days between Period 2 and Period 3. Part 2- Cohort 2 & 3 : Rising multiple dose SCH900931 of 2 cohort in a parallel study design (Cohort 2: 150mg & Cohort 3:250mg). For Part 2, dosing will be once daily for 14 consecutive days for subjects in either Cohort 2 or Cohort 3. Subjects will participate only in Part 1 or in one of the 2 cohorts in Part 2. The first part of the study will determine PK dose proportionality by using 3 single doses. The second part of the study will allow for determination of steady-state PK and accumulation ratio by once daily administration for 14 days.

Sponsors

Schering-Plough Research Institute, a Division of Schering Corporation, a Subsidiary of Merck & Co., Inc
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy Japanese volunteers

Exclusion criteria

History of malignancy, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026