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

Teva Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Contraception

Treatments: Drug: TV-46046; Drug: Depo-subQ 104; Drug: TV-46046 Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03700658

TV46046-WH-10147

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 27 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 4 patient groups, including a placebo group

TV-46046 Undiluted

Experimental group

Description:

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.

Treatment:

Drug: TV-46046

TV-46046 Diluted

Experimental group

Description:

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.

Treatment:

Drug: TV-46046

TV-46046 Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: TV-46046 Placebo

Depo-subQ 104

Active Comparator group

Description:

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.

Treatment:

Drug: Depo-subQ 104