Study of Pharmacokinetics of BMS-708163 in Healthy Subjects

Phase 1

• Registration Number: CTRI/2009/091/000914
• Lead Sponsor: Bristol-Myers Squibb Research and Development311 Pennington-Rocky Hill RoadPennington, NJ 08534

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

1) Signed Written Informed Consent
a) The signed informed consent form.
2) Target Population
a) Healthy Indian subjects as determined by no clinically significant deviation from
normal in medical history, physical examination, ECGs, and clinical laboratory
determinations.
b) Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive.
BMI = weight (kg)/ [height (m)]2.
3) Age and Sex
a) Indian men and postmenopausal women (non-child bearing potential) ages
18 to 55 years of age inclusive

Exclusion Criteria

Sex and Reproductive Status
a) Women of child bearing potential (WOCBP):
WOCBP include any female who has experienced menarche and is not
postmenopausal.
Postmenopause is defined as:
? Amenorrhea ≥12 consecutive months without another cause and a
documented serum FSH level >35 mIU/mL
? Women with irregular menstrual periods and a documented serum FSH level
>35 mIU/mL
? Women on HRT
Women who are using oral contraceptives, other hormonal contraceptives
(vaginal products, skin patches, or implanted or injectable products), or
mechanical products such as an intrauterine device or barrier methods
(diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing
abstinence or where their partner is sterile (eg, vasectomy) should be considered
to be of childbearing potential.
b) Premenopausal women including surgically sterile women having undergone a
hysterectomy, bilateral tubal ligation, or bilateral oophorectomy
c) Women with a positive pregnancy test on enrollment or prior to administration of
investigational product.
d) Women who are pregnant or breastfeeding
e) Sexually active fertile men not using effective birth control (double barrier) if
their partners are WOCBP.
2) Medical History and Concurrent Diseases
a) At risk for tuberculosis (TB) infection. Specifically subjects with:
i) Current clinical, radiographic or laboratory evidence of active or latent TB
ii) A history of active TB within the last 3 years, even if it was treated.
iii) A history of active TB greater than 3 years ago unless there is documentation
that the prior anti-TB treatment was appropriate in duration and type.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measures: <br>?BMS-708163 alone and with rifampin: BMS-708163 single dose PK parameters (Cmax, Tmax, T-HALF, AUC(0-T), AUC(INF), CLT/F and molar AUCmet/AUCparent ratios will be assessed without rifampin (Day 1) and with rifampin (Day 13) [ Time Frame: Within 30 days after dose ] [ Designated as safety issue: No ]Timepoint: Day 1, Day 13 [ Time Frame: Within 30 days after dose

Secondary Outcome Measures

Name	Time	Method
?BMS-708163 alone and with rifampin: Safety and tolerability (AE's, ECG, vital signs, safety labs) [ Time Frame: Within 30 days after dose ] [ Designated as safety issue: Yes ]Timepoint: Time Frame: Within 30 days after dose