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Ortho Tri-Cyclen

Phase 1

Hepatitis C Virus | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Jan 25, 2011

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Ortho Tri-Cyclen · 1 trial · 1 indication

Phase 1 1
NCT01063023Drug Interaction Oral Contraceptive Pill (OCP)Hepatitis C Virus
COMPLETED20 Analytics
PHASE1COMPLETED
Drug Interaction Oral Contraceptive Pill (OCP)
Hepatitis C VirusUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU)
24 hours of dosing

Secondary Endpoints

To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered
Safety will be assessed through day 78
To characterize the PK of norgestrel when Ortho Tri-Cylen® is administered alone and in combination
PK assessments will be done on Day 49, 50, 77 and 78
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
Arm A - Ortho Tri-Cyclen®ACTIVE_COMPARATOR1 to 28 days
Arm B - Ortho Tri-Cyclen®ACTIVE_COMPARATOR29 to 56 days
Arm C - Ortho Tri-Cyclen® + BMS-650032ACTIVE_COMPARATOROrtho Tri-Cyclen®: 57 to 77 days BMS-650032: 68 to 77 days

Interventions

NameTypeDescription
Ortho Tri-Cyclen®DRUGTablets, Oral, 1 Tablet, once daily
BMS-650032DRUGTablets, Oral, 600 mg, BID
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Eligibility Criteria

Age Range18 Years to 40 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Females, 18-40 years, BMI 18 - 32kg/m². Must use an acceptable method of contraception to avoid pregnancy throughout the study and 8 weeks after last dose of study drug Exclusion Criteria: * Abnormal pap smear within 1 year prior to day 1 * Any significant or chronic...

Countries:United States
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Frequently asked questions about Ortho Tri-Cyclen

What is Ortho Tri-Cyclen used for in Hepatitis C Virus?

Ortho Tri-Cyclen is an investigational small molecule being studied for use in Hepatitis C Virus. It is being evaluated in a Phase 1 clinical trial that examines its interaction with an oral contraceptive pill in healthy female volunteers. The drug is not approved and remains in clinical development.

Who makes Ortho Tri-Cyclen?

Ortho Tri-Cyclen is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this drug for Hepatitis C Virus, with one completed Phase 1 trial involving 20 participants.

What phase is Ortho Tri-Cyclen in?

Ortho Tri-Cyclen is in Phase 1 clinical development. It is an investigational drug for Hepatitis C Virus and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains in the early stages of clinical testing.

What clinical trials is Ortho Tri-Cyclen in?

Ortho Tri-Cyclen has been studied in one clinical trial registered as NCT01063023, titled "Drug Interaction Oral Contraceptive Pill (OCP)." This Phase 1 study was completed in the United States and enrolled 20 healthy female volunteers aged 18 years and older. The trial was active-controlled and not randomized or double-blind.

Is Ortho Tri-Cyclen the same as other oral contraceptives?

Ortho Tri-Cyclen is being studied for its potential interaction with oral contraceptive pills in the context of Hepatitis C Virus treatment. The clinical trial specifically evaluates how this drug interacts with an oral contraceptive, but no alternative names for Ortho Tri-Cyclen itself have been established in the research data.