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Period 1, 2 and 3 ABBV-CLS-7262 for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Calico Life Sciences LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately six weeks

Awards & highlights

Study Summary

This trial is testing a medication called ABBV-CLS-7262 on healthy adult participants. The participants will receive a single dose of the medication in a specific order.

Who is the study for?

This trial is for healthy adults aged 18-55 with a BMI of ≥18 to ≤32 kg/m^2. Men must agree to use contraception and not donate sperm, while women should use effective birth control and not donate eggs during the study period.Check my eligibility

What is being tested?

The trial tests ABBV-CLS-7262's behavior in the body when taken with food. It's a randomized study where participants receive a single dose of the drug in different sequences across three periods.See study design

What are the potential side effects?

Since this is an early-phase trial focused on pharmacokinetics (how the drug moves through the body), specific side effects are not listed but may include typical reactions such as nausea, headache, or allergic responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately two weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately two weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately two weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 administered with or without applesauce.

To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food.

Secondary outcome measures

Safety and Tolerability

Trial Design

1Treatment groups

Experimental Treatment

Group I: Period 1, 2 and 3 ABBV-CLS-7262Experimental Treatment1 Intervention

Participants will receive ABBV-CLS-7262 administered under fasted conditions. Participants will receive ABBV-CLS-7262 administered under fed conditions (high-fat/high-calorie breakfast). Participants will receive ABBV-CLS-7262 administered with applesauce.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABBV-CLS-7262

2023

Completed Phase 1

~30

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieIndustry Sponsor

954 Previous Clinical Trials

501,087 Total Patients Enrolled

Calico Life Sciences LLCLead Sponsor

8 Previous Clinical Trials

940 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this medical research study?

"In order to meet the eligibility criteria for this clinical trial, patients must be within the age range of 18 to 55 and exhibit a state of good health. The study is accepting a total of 18 individuals as participants."

Answered by AI

Is there an age restriction that excludes individuals who are above 40 years old from participating in this clinical trial?

"For this particular clinical trial, only patients aged between 18 and 55 are eligible to participate. It is worth noting that there are a total of 61 studies available for participants under the age of 18, while there are 398 studies targeting individuals over the age of 65."

Answered by AI

To what extent does ABBV-CLS-7262 in Period 1, 2, and 3 pose risks to individuals receiving treatment?

"Due to limited data supporting safety and efficacy, the team at Power assigns a safety rating of 1 for Period 1, 2, and 3 ABBV-CLS-7262 in this Phase 1 trial."

Answered by AI

What is the current number of participants being recruited for this clinical investigation?

"Indeed, the information available on clinicaltrials.gov confirms that this trial is actively seeking participants. The initial posting date was December 1st, 2023, and the most recent update occurred on December 15th, 2023. The research team aims to recruit a total of 18 participants from a single site."

Answered by AI

Are new participants still eligible to enroll in this ongoing clinical trial?

"Indeed, the details on clinicaltrials.gov indicate that this ongoing clinical trial is actively seeking individuals to participate. The study was initially posted on December 1st, 2023 and underwent its most recent update on December 15th, 2023. A total of 18 participants are being sought from a single research site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262

2023. "A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06145607.

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