EUCTR2017-003534-89-GB
Active, not recruiting
Phase 1
A Placebo-Controlled, Single-Blind, Single-Center Phase 1 Study in Normal Healthy Volunteers and Open-Label Multi Center Study in Patients with Primary Hyperoxaluria to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DCR PHXC Solution for Injection (subcutaneous use) - 2-part study of DCR-PHXC in NHV and PH patients
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Primary Hyperoxaluria
- Sponsor
- Dicerna Pharmaceuticals Inc
- Enrollment
- 43
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For Part A \& Part B of the study:
- •1\.Subject understands the full nature and purpose of the study, including possible risks and side effects, and is willing and able to comply with all study procedures and restrictions.
- •2\.Females and males and their female partner(s) of childbearing potential must be willing to use a highly effective and approved contraceptive method (s) from the date of informed consent until 12 weeks after the last dose of Investigational Medicinal Product (IMP). A highly effective method of contraception is defined as fulfilling at least one of the following:
- •a.Strict abstinence: When this is in line with the preferred and usual lifestyle of the patient. \[Periodic abstinence (e.g., calendar, ovulation, symptom\-thermal, post\-ovulation methods) and withdrawal are not acceptable methods of contraception.]
- •b.Surgically sterile (having undergone one of the following surgical procedures: hysterectomy, bilateral tubal ligation, bilateral oophorectomy, or bilateral salpingectomy) and at least 6 weeks post\-sterilization.
- •c.Combined hormonal oral contraceptive (estrogen and progesterone), implanted, or injectable contraceptive on a stable dose for at least one month prior to the screening visit plus a barrier method. Combined hormonal contraception is considered a highly effective method of contraception only if it is associated with inhibition of ovulation. If associated with inhibition of ovulation, progesterone\-only hormonal contraception is also considered a highly effective method of contraception.
- •d.Intrauterine devices plus condoms. Hormonal intra\-uterine device (IUD) inserted at least 1 month prior to the screening visit.
- •e.Double\-barrier methods \[e.g., Condom and Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository]. Of note, a female condom and a male condom, or two male condoms, should not be used together as friction between the two can result in either product failing.
- •f.Vasectomized partner (at least 6 months post\-procedure) prior to the screening visit.
- •3\.Postmenopausal females: defined as 12 months with no menses prior to screening and a serum follicle stimulating hormone (FSH) \> 26 IU/L at Screening visit.
Exclusion Criteria
- •Part A and Part B:
- •1\.History of alcohol consumption exceeding more than 21 units in males, 14 units in females, per week as determined by the Investigator.
- •2\.Males with female partners who are planning to attempt to become pregnant during this study or within 90 days after last dosing of IMP.
- •Part A specific:
- •1\.Presence of any medical condition or co\-morbidities that would interfere with study compliance or data interpretation or potentially impact subject safety including, but not restricted to:
- •a.severe intercurrent illness
- •b.routine vaccination within 30 days prior to dosing and through EOS visit
- •c.known causes of active liver disease/ injury or transaminase elevation (e.g., alcoholic liver disease, Nonalcoholic fatty liver disease/ steatohepatitis \[NAFLD/NASH])
- •d.physician concerns about excess alcohol consumption
- •e.routine or chronic use of more than 3 grams of paracetamol daily.
Outcomes
Primary Outcomes
Not specified
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