Healthy Volunteer Study
Conditions
Brief summary
This is a phase 1 single dose, open-label, randomized, two-period, two-sequence, crossover study of ALG-055009 conducted in 1 cohort of healthy volunteers. The primary purpose of this study is to compare the single-dose pharmacokinetics of the 0.7 mg dose level of 2 types of soft gelatin capsule formulations of ALG-055009, Formulation 1 and Formulation 2, in approximately 8 healthy volunteers.
Interventions
DRUGALG-055009
Single PO dose of 0.7 mg ALG-055009 softgel capsule (formulation 1) Single PO dose of 0.7 mg ALG-055009 softgel capsule (formulation 2)
Sponsors
Aligos Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject must sign an informed consent form (ICF) indicating that he or she understands that risks of purpose of and procedures required for, the study and is willing to participate in the study. 2. In the investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned. 3. Male or female between 18 and 65 years of age, extremes included. 4. Subjects must have a bod mass index (BMI) of 18.0 to 32.0 kg/m2, extremes included. 5. Female subjects must be either: 1. Post menopausal: A postmenopausal state is defined as no menses for at least 12 months without an alternative medical explanation . A high follicle-stimulating hormone (FSH) level in the postmenopausal range of \>40 IU may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). OR 2. Permanently Sterile : Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. OR 3. Woman of Childbearing Potential: They are only eligible if they and any non-sterile male sexual partners agree to use highly effective contraceptive therapy from the screening visit until at least 60 days after the last dose of study drug 6. Female subjects must have a negative pregnancy test at screening and Day-1. 7. Female subjects must not be pregnant, or breastfeeding, or planning to become pregnant or donate eggs from screening onward until 60 days after the last dose of study drug (or longer if dictated by local regulation). 8. Male subjects must agree to wear a condom during sexual intercourse and their female sexual partners should agree to use effective means of contraception. These contraceptive measures must be implemented, at a minimum, from the start of dosing until at least 90 days after the last dose. 9. Male subjects must have no plans to father a child or donate sperm while enrolled in this study or within 90 days after the last dose of study drug. 10. Subjects must have a 12-lead ECG that meets the following inclusion criteria 1. Heart rate between 40 and 100 beats per minute (bpm), extremes included; 2. QT interval corrected for heart rate (QTc) according to Fridericia's formula (QTcF) ≤450 ms (males) or ≤470 ms (females); 3. QRS interval ≤120 ms; 4. PR interval ≤110 to ≤220 ms; 5. In addition to fulfilling the above ECG criteria, ECG morphology must have no clinically significant abnormalities observed in the opinion of the Investigator. 11. Subjects must be deemed to be in good overall health by the investigator on the basis of a medical evaluation that reveals the absence of any clinically significant abnormality and includes a physical examination, medical history, vital signs, and the results of blood chemistry, blood coagulation and hematology tests, and a urinalysis performed at screening. 12. Subjects must be willing and able to adhere to the prior and concomitant medications requirements
Exclusion criteria
Any potential subject who meets any of the following criteria will be excluded from participating in the study. 1. Subjects with any current or previous illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation. This may include, but is not limited to renal, cardiac, vascular, pulmonary, gastrointestinal, hepatologic, endocrine, neurologic, dermatologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances. 2. Subjects with medical history or current evidence of a pituitary disorder or thyroid disorder. 3. Subjects with thyroid-stimulating hormone (TSH), free thyroxine (T4) or total triiodothyronine 4. Subjects with known sensitivity to thyroid medications 5. The laboratory values at screening are exclusionary: 1. ALT or AST \> ULN 2. Total bilirubin \> 1.2xULN, unless Gilbert's syndrome is suspected 6. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT syndrome ) or history or clinical evidence at screening of significant or unstable cardiac disease, such as: angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia. 7. History of unexplained syncope. 8. Subjects with current: 1. Hepatitis A virus infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]). 2. Hepatitis B infection defined as presence of HBsAg or HBV core antibody. 3. Hepatitis C virus (HCV) infection (confirmed by HCV antibody and/or HCV RNA). Subjects who have been treated and achieved sustained virologic response ≥6 months prior to screening with HCV RNA \<LLOQ, target not detected, remain eligible. 4. Human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening. 5. Acute infection at the time of enrollment. If an acute infection is considered resolved prior to enrollment, the subject remains eligible. 9. Subjects who had major surgery (e.g., requiring general anesthesia) within 12 weeks before randomization, or will not have fully recovered from surgery, or have surgery planned during the time the subjects is expected to participate in the study, or within 4 weeks after the last dose of study drug 10. Subjects with a recent (within 1 year of randomization/enrollment) history of use of amphetamines, barbiturates, narcotic or other drugs of abuse/recreational drug use. Use of these drugs under physician supervision (e.g., prescription narcotics for known pain disorder) are not exclusionary. Cannabis use within 4 weeks of screening and during the study is exclusionary. 11. Excessive use of alcohol defined as regular consumption of ≥14 standard drinks/week for women and ≥21 standard drinks/week for men (Chalasani et al. 2018). For current definition of a standard drink, please refer to the National Institute on Alcohol Abuse and Alcoholism website (https://www.niaaa.nih.gov/what-standard-drink). 12. Unwilling to abstain from alcohol use for 48 hours prior to Day -1 through end of study follow up. 13. Positive results for urine drug screen or alcohol test at screening or Day -1. 14. Any laboratory result considered clinically significant by the Investigator at screening. Values of ALT and AST \>ULN, and total bilirubin \>1.2×ULN (see
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| t½ of ALG-055009 in Plasma | 12 days | t½ of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2 |
| AUC0-24 of ALG-055009 in Plasma | 12 days | AUC0-24, of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2 |
| AUClast of ALG-055009 in Plasma | 12 days | AUClast of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2 |
| AUCinf of ALG-055009 in Plasma | 12 days | AUCinf of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2 |
| Tmax of ALG-055009 in Plasma | 12 days | Tmax of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2 |
| Cmax of ALG-055009 in Plasma | 12 days | Cmax of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2 |
| C24 of ALG-055009 in Plasma | 12 days | C24 of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2 |
| C0 (predose) of ALG-055009 in Plasma | 12 days | C0 (predose) of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Data | 22 days | The number and severity of treatment emergent adverse events as assessed by CTCAE v5.0 |
Countries
United States
Outcome results
None listed