- Male or female, above 18 years of age and Body Mass Index (BMI) of 18.0 to 25.0 kg/m2,
inclusive;
- Subjects must have received a primary or secondary renal allograft for at least 2
months prior to Screening;
- Subjects must be currently taking Rapamune tablets for prophylaxis of renal rejection.
The dosages of any medications must be stable for at least 2 weeks prior to screening
and continue with no change until completion of the last PK sample collection.
- Acute rejection or vascular rejection episode in the 4 weeks prior to Screening; or
patients dependent on dialysis; or inadequate renal function (in the opinion of the
investigator);
- Recipients of multiple organ transplants (i.e., prior or concurrent transplantation of
any organs other than renal transplant);
- Current use of strong inducers or inhibitors of CYP3A4 within 2 weeks prior to
collection of the first PK sample and until collection of the final PK sample;
- Any clinically significant medical or psychiatric condition or laboratory abnormality,
in the judgment of the investigator.