A Phase 1 Study to Evaluate the Drug-Drug Interaction Potential Between ALG-055009 and Statin Therapy(Ies)

NCT06191991 | Completed Phase 1 FDA Drug

• 1 other identifier: ALG-055009-302
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase 1 study consists of two parts, all conducted in healthy volunteers (HVs). In Parts 1 and 2, the drug-drug interaction (DDI) potential of ALG-055009 will be explored, where subjects will be assigned to receive multiple doses of ALG-055009 and 2 single doses of one of the following concomitant drugs: atorvastatin (Part 1), or rosuvastatin (Part 2, optional).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (12)

• Area under the concentration time curve [AUC]

  Pharmacokinetic parameters of atorvastatin and applicable metabolites

  23 days

• Time to maximum plasma concentration [Tmax]

  Pharmacokinetic parameters of atorvastatin and applicable metabolites

  23 days

• Maximum plasma concentration [Cmax]

  Pharmacokinetic parameters of atorvastatin and applicable metabolites

  23 days

• Minimum plasma concentration [Cmin]

  Pharmacokinetic parameters of atorvastatin and applicable metabolites

  23 days

• C0 [predose]

  Pharmacokinetic parameters of atorvastatin and applicable metabolites

  23 days

• Half-life [t1/2]

  Pharmacokinetic parameters of atorvastatin and applicable metabolites

  23 days

• Area under the concentration time curve [AUC]

  Pharmacokinetic parameters of rosuvastatin and applicable metabolites

  22 days

• Time to maximum plasma concentration [Tmax]

  Pharmacokinetic parameters of rosuvastatin and applicable metabolites

  22 days

• Maximum plasma concentration [Cmax]

  Pharmacokinetic parameters of rosuvastatin and applicable metabolites

  22 days

• Minimum plasma concentration [Cmin]

  Pharmacokinetic parameters of rosuvastatin and applicable metabolites

  22 days

• C0 [predose]

  Pharmacokinetic parameters of rosuvastatin and applicable metabolites

  22 days

• Half-life [t1/2]

  Pharmacokinetic parameters of rosuvastatin and applicable metabolites

  22 days

Secondary Outcomes (21)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  up to 23 days for part 1

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Up to 22 days for part 2

• Time to maximum plasma concentration [Cmax] of ALG-055009 (ng/mL)

  up to 23 days for part 1

• Minimum plasma concentration [Cmin] of ALG-055009 (ng/mL)

  up to 23 days for part 1

• Area under the concentration time curve [AUC] of ALG-055009 (ng/mL)PK

  up to 23 days for part 1

Other Outcomes (2)

• Cholesterol

  up to 23 days for part 1

• Cholesterol

  Up to 22 days for part 1

Study Arms (2)

Atorvastatin with ALG-055009

EXPERIMENTAL

Single dose PO administration of 40 mg atorvastatin (Day 1), then a washout period of at least 2 days, followed by PO QD administration of 0.9 mg ALG-055009 for 14 days (Days 3-16) and single dose PO administration of 40 mg atorvastatin (Day 15).

Drug: Atorvastatin; Drug: ALG-055009

Rosuvastatin with ALG-055009 (optional)

EXPERIMENTAL

Single dose PO administration of 10 mg rosuvastatin (Day 1), then a washout period of at least 4 days, followed by PO QD administration of 0.9 mg ALG-055009 for 11 days (Days 5-15) and single dose PO administration of 10 mg rosuvastatin (Day 11).

Drug: ALG-055009; Drug: Rosuvastatin

Interventions

Atorvastatin DRUG

40 mg

Atorvastatin with ALG-055009

ALG-055009 DRUG

0.9 mg

Atorvastatin with ALG-055009; Rosuvastatin with ALG-055009 (optional)

Rosuvastatin DRUG

10 mg

Rosuvastatin with ALG-055009 (optional)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
• 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.
• Male or female between 18 and 65 years of age, extremes included.
• Female subjects must not be a woman of childbearing potential defined as:
• Postmenopausal:
• A postmenopausal state is defined as no menses for at least 12 months without an alternative medical explanation, confirmed by a high follicle-stimulating hormone (FSH) level in the postmenopausal range at screening.
• Permanently sterile:
• Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
• Male subjects must agree to wear a condom during sexual intercourse and their female sexual partners should agree to use effective means of contraception (Section 7.2.3). These contraceptive measures must be implemented, at a minimum, from the start of dosing until at least 90 days after the last dose.
• NOTE: Contraceptive use should be consistent with local regulations regarding the use of contraceptive methods for subjects participating in clinical studies.
• Subjects must have a body mass index (BMI) of 18.0 to 32.0 kg/m2, extremes included.
• Subjects must be nonsmokers for at least 3 months prior to enrollment.
• Subjects must have a 12-lead electrocardiogram (ECG) that meets the following criteria at screening:
• Heart rate between 40 and 100 beats per minute \[bpm\], extremes included;
• QT interval corrected for heart rate (QTc) according to Fridericia's formula (QTcF) \<450 ms (males) or \<470 ms (females);

You may not qualify if:

• Subject with a) a medical history of thyroid disorder or b) abnormal thyroid stimulating hormone (TSH), free thyroxine (T4) or total triiodothyronine (T3) during screening, and Day -1 or c) known sensitivity to thyroid medications.
• ALT or AST \> upper limit of normal (ULN),
• Total bilirubin \>1.2× ULN, unless Gilbert's Syndrome is suspected
• 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.
• History of unexplained syncope.
• Subjects with a history of clinically significant (in the opinion of the Investigator) drug allergy such as, but not limited to, sulfonamides or drug allergy witnessed in previous studies with experimental drugs.
• Subjects with a recent (within 1 year of enrollment) history or current evidence of use of amphetamines, barbiturates, narcotic or other drugs of abuse/recreational drug use (including cannabis).
• 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).
• Unwilling to abstain from alcohol use for 1 week prior to start of study through end of study follow up.
• Positive results for urine drug screen, alcohol or cotinine test at screening and Day -1.
• Subjects with current:
• Hepatitis A virus infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]).
• Hepatitis B infection defined as presence of HBsAg or HBV core antibody.
• Hepatitis C virus (HCV) infection (confirmed by HCV antibody and/or HCV RNA).
• Hepatitis E virus: Anti-HEV IgM-positive and/or detectable HEV RNA level.

Sponsors & Collaborators

• Aligos Therapeutics: lead

Study Sites (1)

PPD Austin Research Unit

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

Atorvastatin; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: January 5, 2024
• Study Start: November 3, 2023
• Primary Completion: November 27, 2023
• Study Completion: December 4, 2023
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

US (1)