A Study to investigate the safety of ACH-0145548 in Healthy Participants

Phase 1

Completed

• Conditions: Complement-mediated diseases; Inflammatory and Immune System - Autoimmune diseases

• Registration Number: ACTRN12618000896279
• Lead Sponsor: Achillion Pharmaceuticals. Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-28
• Study Completion: 2019-02-04
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Participant must be 25 to 55 years of age, inclusive, at the time of signing the informed consent.
2. Participants who are overtly healthy as determined by medical evaluation including detailed medical history, physical examination, blood pressure (BP) and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
3. Body weight of at least 50 kg and body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive).
4. Male or Female
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
a. Male participants
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days (a spermatogenesis cycle) after administration of study drug:
Refrain from donating sperm
PLUS either:
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
OR
Must agree to use a highly effective method of contraception with their partner(s) of childbearing potential. Their female partner(s) of childbearing potential must also agree to use a highly effective form of contraception for the same period.
b. Female participants:
Female participants must be of non-childbearing potential as defined by one of the following:
Surgical sterilization by hysterectomy removal of uterus), bilateral salpingo-oophorectomy (removal of both ovaries and fallopian tubes) or bilateral oophorectomy (removal of both ovaries) at least 6 months prior to dosing
Post-menopausal with amenorrhea (absence of menstrual periods) for at least 1 year prior to dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status
5. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria

1. Have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders or conditions capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
2. Have a history of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration
3. Have a history of meningococcal infection, or a first-degree relative with a history of meningococcal infection
4. Current or chronic history of liver disease or known hepatic or biliary abnormalities (including biliary cholestasis or Gilbert's syndrome)
5. Subjects with a female partner who is pregnant, nursing, or planning to become pregnant during the confinement phase of the study or within 90 days of study drug administration.
6. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study
7. History of hypersensitivity reactions to beta-lactams, penicillin, aminopenicillins, fluoroquinolones, cephalosporins, and carbapenems
8. Use of prohibited over-the-counter or prescription medications as follows:
Prescription medications (systemic and topical) within 14 days prior to first study drug administration (or when known, 5 half-lives, whichever is longer) through study completion, including follow-up visits
Non-prescription medications (including lipid-soluble vitamins A, D, E, and K [water-soluble vitamins B and C are not prohibited], herbal supplements, and dietary supplements) within 14 days of first study drug administration
Medications known to induce or inhibit hepatic microsomal enzyme cytochrome P450 (CYP450) activity (e.g., quinines) within 28 days of first study drug administration
Hormonal therapy/replacement medications within 28 days of first study drug administration
9. Live attenuated vaccine within 30 days or other vaccine within 14 days of first study drug administration
10. Donated blood or lost more than 500 ml of blood within 3 months prior to first study drug administration, or received a blood transfusion or blood products within 6 months prior to first study drug administration
11. Current enrolment or past participation within the last 30 days before study drug administration in any clinical study involving an investigational study intervention or any other type of medical research
12. Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to dosing
13. Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
14. Positive human immunodeficiency virus (HIV) antibody test
15. Positive serum hCG (female participants only)
16. Have clinically significant laboratory abnormalities, including any of the following, at either screening or Day -1 :
Serum creatinine greater than ULN and/or creatinine clearance less than 80 mL/minute estimated by the Cockcroft-Gault formula [(140 - age) × weight (kg) / 72 × serum creatinine (mg/dL)]
Alanine transaminase greater than ULN
Aspartate transaminase greater than ULN
Alkaline phosphatase greater than ULN
Total bilirubin greater than 1.5 × ULN
Absolute neutrophil count (ANC) less than lower limit of normal (LLN)
Absolute

Study & Design

• Study Type: Interventional
• Study Design: Not specified