Assessment of the trial drugs ACH­-0143102 and ACH-0142684, when taken by healthy men and women.

Phase 1

Completed

• Conditions: Phase 1 study (Healthy volunteers). Results to support research in Hepatitis C.; Infection - Other infectious diseases

• Registration Number: ACTRN12614000102673
• Lead Sponsor: Achillion Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Healthy, adult, male or female subjects, 18 to 55 years of age, inclusive.
2. Continuous non smokers who have not used nicotine containing products for at least 3 months prior to the first dose.
3. Weigh at least 50kg and have a Body Mass Index (BMI) in the range 18 to 30.
4. Medically healthy with no clinically significant laboratory profiles, vital signs or ECGs; as assessed by the PI.
5. Liver function tests (serum alanine transaminase [ALT], aspartate transaminase [AST], alkaline phosphatase [ALP]) and serum bilirubin (total and direct) must be below or equal to the upper limit of normal (ULN) at screening.
6. Females must be of non childbearing potential, defined as having undergone one of the following sterilization procedures at least 6 months prior to Day 1:
hysterectomy;
bilateral oophorectomy
bilateral tubal ligation or fallopian tube inserts or be postmenopausal with amenorrhea for at least 1 year prior to Day 1 and have follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status.
7. Males must use a condom with spermicide when engaged in sexual activity from first check in through 90 days beyond the last dose.
8. Males must agree to refrain from sperm donation from first check in through 90 days beyond the last dose.
9. Give voluntary written informed consent to participate in the study.
10. Able to effectively communicate with the Investigator and other center personnel, and willing to comply with all study requirements and restrictions.

Exclusion Criteria

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease in the opinion of the PI.
2. History or presence of alcoholism and/or drug abuse within the past 2 years.
3. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
4. History or presence of diabetes mellitus or hyperglycemia, in the opinion of the PI.
5. Female subjects who are pregnant or lactating.
6. Have positive results for the urine drug screen at screening or check in.
7. Have positive urine cotinine at screening.
8. Have positive results at screening for HIV, HBsAg or HCV.
9. Seated sustained blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
10. Heart rate is lower than 40 bpm or higher than 99 bpm at screening.
11. 12 lead ECGs which have clinically significant findings as judged by the PI or the PI’s designee at screening and prior to dosing, including:
QTcB interval is >450 msec;
PR interval > 200 msec.
QRS interval > 120 msec.
12. Has an estimated creatinine clearance < 90 mL/min based on the Cockcroft Gault equation at the screening visit.
13. Have used any drugs or substances known to be significant inhibitors of CYP enzymes and/or significant inhibitors or substrates of P gp and/or OATP within 14 days prior to the assigned first dose of study drug.
14. Have used any drugs or substances known to be significant inducers of CYP enzymes and/or P gp within 28 days prior to the assigned first dose of study drug.
15. Have been on a special diet within the previous 28 days which, in the opinion of the investigator, would interfere with subject safety or compliance with the protocol.
16. Have a hemoglobin level below the lower limit of normal at screening and first check in.
17. Have made a donation of blood or had significant blood loss within 56 days prior to the assigned first dose of study drug.
18. Have participated in another clinical trial within 28 days prior to the assigned first dose of study drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified