ImQuest (IQP) DuoGel Phase 1 Pharmacokinetic Study

NCT03082690 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: IRB000410895U19AI101961
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is describe the safety and single-dose pharmacokinetics of rectally-administered IQP (ImQuest Pharmaceuticals)-0528 (DuoGel) in plasma, rectal tissue biopsies, vaginal tissue biopsies, rectal fluid and cervicovaginal fluid as well as to assess the luminal distribution of IQP-0528 in the rectum. Sixteen healthy volunteers will receive a single rectal dose of DuoGel, followed by blood, tissue and fluid sampling over the following 72 hours.

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (5)

• To assess systemic and local safety of 10 mL of IQP-0528 following rectal administration by adverse events.

  Grade 2 or above adverse events as measured by the Division of AIDS Toxicity Table

  One week

• To assess rectal PK of 10 mL of IQP-0528

  Maximum Concentration (Cmax)

  72 hours

• To assess rectal PK of 10 mL of IQP-0528

  Time to Maximum Concentration (Tmax)

  72 hours

• To assess rectal PK of 10 mL of IQP-0528

  Area Under the Curve (AUC)

  72 hours

• To assess rectal PK of 10 mL of IQP-0528

  Terminal elimination half-life

  72 hours

Secondary Outcomes (4)

• To compare rectal PK between men and women

  72 hours

• To compare rectal PK between men and women

  72 hours

• To compare rectal PK between men and women

  72 hours

• To compare rectal PK between men and women

  72 hours

Study Arms (1)

DuoGel

EXPERIMENTAL

IQP-0528 1% gel administered rectally one time

Drug: DuoGel

Interventions

DuoGel DRUG

1% IQP-0528 in gel formulation

Also known as: IQP-0528

DuoGel

Eligibility Criteria

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

You may qualify if:

• years or older at screening
• HIV-1 negative as documented at screening
• Willing to use condoms for the duration of the study
• Willing to refrain from aspirin and non-steroidal anti-inflammatory drug (NSAID) use for one week before and after each study biopsy visit
• Available to return for all study visits
• Agrees to sexually transmitted infection (STI) reporting requirements
• Able and willing to communicate in English
• Able and willing to provide written informed consent
• Able and willing to provide adequate information for locator purposes
• Agrees not to participate in other research studies
• Willing to refrain from receptive anal intercourse and insertion of anything in the rectum for 72 hours before and after rectal biopsies.
• Be pre-menopausal
• Have regular menstrual cycles (unless on contraception that causes amenorrhea or irregular menses)
• Have a negative qualitative urine pregnancy test
• Per participant report, using an effective method of contraception at enrollment; hormonal method (except vaginal ring) used continuously for the past 30 days; intrauterine device (IUD \[copper or hormonal\] inserted at least 30 days prior to enrollment); female sterilization; abstinent from sexual activity with male partner for the past 30 days; or sexual activity with vasectomized partner; and willingness to use effective method of contraception until the completion of final scheduled study visit if enrolled.

You may not qualify if:

• Current known HIV-infected partners
• Current use of anticoagulant medications associated with increased risk for bleeding following mucosal biopsy (e.g., daily high dose aspirin \[\>81 mg\], NSAIDs, or Pradaxa®)
• Current use of cytochrome P450 3A (CYP3A) inducer(s) and/or inhibitor(s)
• Use of systemic immunomodulatory medications within 4 weeks of enrollment
• Known allergic reaction to components of the study product
• History of recurrent urticaria
• Participants whose whole body radiation exposure exceeds 5000 millirem (mRem)/year.
• Participants who are currently receiving or have been on oral PrEP or PEP in the past month
• Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
• Significant colorectal symptom(s) as determined by medical history or by participant self-report
• Active rectal infection, requiring treatment per current Centers for Disease Control (CDC) guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include Chlamydia (CT), gonorrhea (GC), syphilis, active herpes simplex virus (HSV) lesions, chancroid, genital sores or ulcers, and, if clinically indicated, genital warts.
• History of STI within the last 3 months.
• Use of post-exposure (PEP) or pre-exposure (PrEP) prophylaxis within the last 6 months
• History of significant gastrointestinal bleeding
• Use of any rectally administered medications within 4 weeks of enrollment or unwillingness to refrain from use of any rectally administered medications 72 hours prior to any study dosing or biopsy visit

Sponsors & Collaborators

• Johns Hopkins University: lead
• ImQuest Pharmaceuticals, Inc.: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Al-Khouja A, Shieh E, Fuchs EJ, Marzinke MA, Bakshi RP, Hummert P, Ham AS, Buckheit KW, Breakey J, Weld ED, Chen H, Caffo BS, Buckheit RW, Hendrix CW. Examining the Safety, Pharmacokinetics, and Pharmacodynamics of a Rectally Administered IQP-0528 Gel for HIV Pre-Exposure Prophylaxis: A First-In-Human Study. AIDS Res Hum Retroviruses. 2021 Jun;37(6):444-452. doi: 10.1089/AID.2020.0188. Epub 2021 Jan 25.

  PMID: 33371779 DERIVED

MeSH Terms

Interventions

IQP-0528

Study Officials

• Craig Hendrix, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: March 17, 2017
• Study Start: November 1, 2017
• Primary Completion: May 30, 2019
• Study Completion: June 2, 2019
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)