ImQuest (IQP) DuoGel Phase 1 Pharmacokinetic Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a phase 1 open label study of the safety, PK, and PD of single-dose 10 mL IQP-0528 through rectal administration. Pharmacokinetics (PK) will be assessed in multiple compartments: plasma, rectal tissue, vaginal tissue, rectal fluid and cervicovaginal fluid. The luminal distribution of DuoGel in the rectum will be evaluated with Single Photon Emission Computed Tomography/ X-ray Computed Tomography (SPECT/CT). Pharmacodynamics (PD) will be assessed in an ex vivo HIV explant challenge of rectal and vaginal tissue biopsies.

After completing the screening evaluation (Visit 1) and establishing participant eligibility, 16 eligible participants will be enrolled: 8 men and 8 women. A subsequent baseline visit (Visit 2) safety assessment and tissue ex vivo HIV explant challenge will be performed as baseline for comparison with later post-drug evaluation. Participants will receive a single 10 mL rectal dose of 99mTechnetium (99mTc) -radiolabelled DuoGel (Visit 3), followed by safety assessments and PK and PD sampling over three days (Visits 3, 4, and 5). Finally, a follow-up safety phone call is performed a week after all PK sampling and biopsies are collected. ;

Study Design

Related Conditions & MeSH terms

HIV Prevention

Clinical Trial Details

NCT number	NCT03082690
Study type	Interventional
Source	Johns Hopkins University
Contact
Status	Completed
Phase	Phase 1
Start date	November 1, 2017
Completion date	June 2, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03411577` - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program	N/A
Active, not recruiting	`NCT03112369` - Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use	N/A
Not yet recruiting	`NCT03642314` - HIV Self-testing in Implementation PrEP Study	N/A
Completed	`NCT01810315` - Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity	Phase 1
Completed	`NCT00984971` - Rectal Microbicide Safety and Acceptability Trial of Topically Applied Tenofovir Compared With Oral Tablet	Phase 1
Completed	`NCT00142935` - Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1	N/A
Active, not recruiting	`NCT03255915` - PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study)	Early Phase 1
Completed	`NCT05037513` - Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky	N/A
Recruiting	`NCT05087680` - An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South	N/A
Recruiting	`NCT05804461` - Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico	N/A
Completed	`NCT03148171` - Project WERK (Wellness Encouragement Respect Kinship)	N/A
Completed	`NCT04791007` - OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults	Early Phase 1
Recruiting	`NCT05412433` - Clinic-based HIV Identification and Prevention Project Using Electronic Resources	N/A
Active, not recruiting	`NCT03977181` - The Community PrEP Study to Assess the Acceptance of PrEP Delivered Through CBCT Platforms	N/A
Recruiting	`NCT05165745` - Stick2PrEP Cisgender Women and Trans Individuals	N/A
Completed	`NCT03719053` - Single Dose Truvada Study	Phase 1
Recruiting	`NCT03856580` - Long-acting Biomedical HIV Prevention in Transgender Women	N/A
Completed	`NCT02750540` - Optimization of a Tenofovir Enema for HIV Prevention	Phase 1
Completed	`NCT01386294` - Safety and Effectiveness of Tenofovir Gel in the Prevention of Human Immunodeficiency Virus (HIV-1) Infection in Women and the Effects of Tenofovir Gel on the Incidence of Herpes Simplex Virus (HSV-2) Infection	Phase 3
Completed	`NCT00993811` - The Shang Ring: A Novel Male Circumcision Device for HIV Prevention	Phase 1