A Study to Evaluate Injection Pain and Local Tolerability Following Subcutaneous (SC) Administration of TV-46046

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2020-10-02

Brief Summary

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The purpose of this study is to evaluate the local tolerability associated with the SC administration of TV-46046, and inform next steps of the TV-46046 development program.

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Detailed Description

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Eligible participants will be enrolled and receive 1 of each of the 4 SC study injections in each abdominal quadrant approximately 1 hour apart: 120 milligrams (mg)/0.3 milliliter (mL) of TV-46046, 60 mg/0.3 mL of 1:1 saline diluted TV-46046, 0.3 mL of TV-46046 Placebo and 104 mg/0.65 mL Depo-subQ 104 per the assigned sequence.

Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

The study will be partially blinded due to differences in appearance and volume of the treatments. Designated unblinded study staff will conduct randomization procedures. The staff preparing and administering injections will also be unblinded to treatment sequence but will be trained to shield the syringe prior to and at the time of injection from view of the participant and study staff assessing injection site reactions (ISRs).

Study Groups

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TV-46046 Undiluted

Participants will receive TV-46046 undiluted (120 mg/0.3 mL of 400 mg/mL) SC injection as a test formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart.

Group Type EXPERIMENTAL

TV-46046

Intervention Type DRUG

TV-46046 will be administered per dose and schedule specified in the arm.

TV-46046 Diluted

Participants will receive TV-46046 saline-diluted (60 mg/0.3 mL of 200 mg/mL) SC injection as a test formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart.

Group Type EXPERIMENTAL

TV-46046

Intervention Type DRUG

TV-46046 will be administered per dose and schedule specified in the arm.

TV-46046 Placebo

Participants will receive TV-46046 placebo (0.3 mL) SC injection in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart.

Group Type PLACEBO_COMPARATOR

TV-46046 Placebo

Intervention Type DRUG

TV-46046 Placebo will be administered per schedule specified in the arm.

Depo-subQ 104

Participants will receive Depo-subQ 104 (medroxyprogesterone acetate injectable suspension; 104 mg/0.65 mL) SC injection as a reference formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart.

Group Type ACTIVE_COMPARATOR

Depo-subQ 104

Intervention Type DRUG

Depo-subQ 104 will be administered per dose and schedule specified in the arm.

Interventions

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TV-46046

TV-46046 will be administered per dose and schedule specified in the arm.

Intervention Type DRUG

Depo-subQ 104

Depo-subQ 104 will be administered per dose and schedule specified in the arm.

Intervention Type DRUG

TV-46046 Placebo

TV-46046 Placebo will be administered per schedule specified in the arm.

Intervention Type DRUG

Other Intervention Names

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Medroxyprogesterone acetate injectable suspension Depo-subQ Provera 104®

Eligibility Criteria

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Inclusion Criteria

* Participant has a low risk of pregnancy (that is, sterilized, in exclusively same-sex partnership, in menopause and/or post-menopausal, abstinent, in a monogamous relationship with vasectomized partner, using nonhormonal intrauterine device \[IUD\], or consistent use of condoms)
* Participant is not pregnant and does not have desire to become pregnant in the subsequent 18 months
* Participant had a normal mammogram within the last year, if 40 years or older
* Participant has no skin disorders or skin allergies

* Additional criteria apply, please contact the investigator for more information

Exclusion Criteria

* Participant has hypertension
* Participant has ischemic heart disease or a history of ischemic heart disease
* Participant has a history of stroke
* Participant has a history of thromboembolic event(s)
* Participant has systemic lupus erythematosus
* Participant has rheumatoid arthritis and is undergoing immunosuppressive therapy
* Participant has migraine with aura
* Participant has unexplained vaginal bleeding
* Participant has diabetes
* Participant has a strong family history of breast cancer
* Participant has cervical cancer or a history of cervical cancer
* Participant has severe cirrhosis (decompensated) or liver tumors
* Participant has known significant renal disease
* Participant has a history of diagnosed clinical depression or bipolar disorder, with or without suicidal ideation, and/or history of suicide attempt
* Participant is currently using hormonal contraception
* Participant had an injection of DMPA (Depo-Provera CI or Depo-subQ 104) in the past 12 months; or combined injectable in the last 3 months
* Participant is chronically using pain medication
* Participant has a plan to move to another location in the next 18 months

* Additional criteria apply, please contact the investigator for more information

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes