A Study of Single Ascending Doses of STAR-101 in Healthy Participants

NCT04081597 | Withdrawn Phase 1 DMC

• 1 other identifier: ACANTHAS-P1-101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will include a single ascending dose approach to evaluate the safety, tolerability, and pharmacokinetic properties of STAR-101 after a single oral administration in healthy participants

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Number of participants with Serious Adverse Events (SAEs)

  A summary of SAEs and other non-serious adverse events (AEs) will be reported in the Adverse Events module

  Baseline to approximate 70 days

• Number of participants with other (non-serious) adverse events

  A summary of SAEs and other non-serious adverse events (AEs) will be reported in the Adverse Events module

  Baseline to approximate 70 days

Secondary Outcomes (6)

• Area under the drug concentration time curve (AUC0 to t-last)

  Predose up to 144 hours post dose

• Area under the drug concentration time curve (AUC0-24)

  Predose up to 24 hours postdose

• Area under the drug concentration time curve (AUC0-inf)

  Predose up to 144 hours post dose

• Maximum observed drug concentration (Cmax)

  Predose up to 144 hours post dose

• Time to reach Cmax (Tmax)

  Predose up to 144 hours post dose

Study Arms (2)

STAR-101

EXPERIMENTAL

Doses in two of three crossover periods

Drug: Star-101

Placebo

PLACEBO COMPARATOR

Matching placebo in one of three periods

Drug: Placebo

Interventions

Star-101 DRUG

Administered orally

STAR-101

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male participants who are not vasectomized for at least 6 months and having a female partner of childbearing potential (childbearing potential females are defined as women that are neither post-menopausal nor surgically sterile) must agree to use a reliable method of birth control
• Simultaneous use of a male condom and, for the female partner, hormonal contraceptives (used since at least 4 weeks) or intra-uterine contraceptive device(placed since at least 4 weeks) or abstain from sexual intercourse from start of study drug dosing until 90 days after dosing with study drug
• Simultaneous use of a male condom and, for the female partner, a diaphragm or cervical cap with intravaginally applied spermicide from start of study drug dosing until 90 days after dosing with study drug
• Male participants (including vasectomized males) with a pregnant partner must agree to use a condom from start of study drug dosing until 90 days after dosing with study drug
• No contraception is required for a vasectomized male, provided his vasectomy was performed 6 months or more prior to screening and his female partner is not pregnant, and for a male participant with a female partner of non-childbearing potential.
• A male who was vasectomized less than 6 months prior to screening must follow the same restrictions as a non-vasectomized male
• Males participants must not donate sperm at any time from start of study drug dosing until 90 days after study drug dosing
• Healthy female participants must be nonpregnant and not lactating. Female participants of childbearing potential with a non-sterile male partner (sterile male partners are defined as men vasectomized since at least 6 months) must be willing and able to practice effective contraception from the period described below and for at least 30 days after the study completion. For this study, acceptable contraception includes:
• Simultaneous use of intrauterine contraceptive device, without hormone release system, placed at least 4 weeks prior to study drug dosing, and cond om for the male partner
• Simultaneous use of diaphragm or cervical cap with intravaginally applied spermicide and male condom for the male partner, started at least 21 days prior to study drug dosing
• Sexual abstinence if this is usual and preferred lifestyle choice of participant
• Have a body mass index of greater than or equal to (≥18.5) and less than \<30.0 kilogram - meter squared (kg/m2) and body weight ≥50.0 kilograms (kg) for males and ≥45.0 kg for females
• Have given informed consent prior to any study specific- procedures.
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow Clinical Research Unit (CRU) specific- study procedures.
• Have clinical laboratory test results within normal reference range for the population or Investigator site, or results with acceptable deviations that are judged not clinically significant by the Investigator

You may not qualify if:

• Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to study drug dosing, administration of a biological product in context of a clinical research study within 90 days prior to study drug dosing, or currently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• Have previously completed or withdrawn from this study or any other study investigating STAR-101
• Have a clinically significant history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric, immunological, gastrointestinal, renal, metabolic or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation
• Have an abnormality in the 12-lead ECG that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, participants with the following findings will be excluded:
• Confirmed Frederica's corrected QT (QTcF) interval greater than ( \>) 450 msec (milliseconds)
• Personal or family history (in a first degree relative) of QT prolongation.
• Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen
• Have donated plasma within 7 days prior to study drug dosing or have donated or lost blood from to 50 (milliliter) mL to 499 mL within 30 days, or more than 499 mL within 56 days prior to study drug dosing
• Are unwilling to stop alcohol and caffeinated beverage consumption for the restriction periods stated
• Use of tobacco or nicotine products within 3 months prior
• Have a history of significant alcohol abuse within 1 year prior or an average weekly alcohol intake that exceeds 14 units per week (1 unit = 12 ounces (oz) or 360 mL of beer; 5oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
• Have an abnormal blood pressure (supine) defined as diastolic blood pressure \>90 or \<50 (millimeters of mercury (mmHg) and/or systolic blood pressure \>140 or \<90 mmHg and/or heart rate\>100 bpm or \<50 (beats per minute) bpm
• Have following abnormal laboratory results
• Alanine transaminase (ALT) or aspartate transaminase (AST) \>1.5x upper limit of normal (ULN)
• Hemoglobin, white blood cell count, platelets, c-reactive protein, or glucose outside or the normal range

Sponsors & Collaborators

• Acanthas Pharma Inc: lead

Study Officials

• Acanthas Pharma

  Acanthas Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: February 1, 2020
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: February 13, 2020

Record last verified: 2019-11