A Phase 1 interventional study of BMS-663068 and Oral Contraceptive in Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare. Completed at 2 sites in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-27.
Sponsored by ViiV Healthcare · Phase 1, Interventional, and Treatment
This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI) study in healthy female subjects on oral contraceptives (OC). There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-663068 with OC will not affect the pharmacokinetics (PK) of either ethinyl estradiol (EE) or norethindrone (NE).
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 26 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol defined exclusion criteria could apply.
Treatment A/Cycle 1: OC containing EE and progestin taken by mouth. Treatment B/Cycle 2: OC containing EE and progestin taken by mouth. Treatment C/Cycle 3: Loestrin 1.5/30 taken by mouth. Treatment D/Cycle 4: Loestrin 1.5/30 (alone) and Loestrin 1.5/30 with BMS-663068 taken by mouth.
Drug: BMS-663068 · Drug: Oral Contraceptive · Drug: Loestrin 1.5/30
Investigational product
Subject's existing combination OC tablet containing EE and progestin
OC containing EE and norethindrone acetate (NEA)
Also known as: Junel, Microgestin 1.5/30
Pharmacokinetic parameter Cmax
Pharmacokinetic parameter includes: maximal observed concentration (Cmax) for EE and NE.
Time frame: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Pharmacokinetic parameter AUC TAU
Pharmacokinetic parameter includes: area under the concentration-time curve in one dosing interval (AUC(TAU)) for EE and NE.
Time frame: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Clinical Safety as Measured by Adverse Event Monitoring.
Adverse event monitoring
Time frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Clinical Safety as Measured by the Collection of Vital Signs.
Vital signs assessments
Time frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Clinical Safety as Measured by the Collection of Electrocardiograms (ECGs).
12-lead ECGs
Time frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Clinical Safety as measured by Physical Examination.
Physical examinations
Time frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Clinical Safety as Measured by Clinical Laboratory Evaluations.
clinical chemistry, hematology, and urinalysis.
Time frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Pharmacokinetic Parameter
Pharmacokinetic parameter: -time of maximum observed concentration (Tmax) for EE and NE.
Time frame: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
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