A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | November 2012 |
| End Date: | January 2016 |
Phase 1 Open Label Safety, Acceptability, Pharmacokinetic and ex Vivo Pharmacodynamic Study of TMC278 Long Acting (LA) Administered Intramuscularly to HIV-1 Seronegative Individuals
The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics (what
the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics
(what the medication does to the body) of TMC278 long acting (slowly effective after initial
dosage and maintaining its effects over a long period of time) when administered as an
intramuscular (ie, in to the muscle) injection in adult participants who are seronegative
for human immunodeficiency virus type 1 (HIV-1).
the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics
(what the medication does to the body) of TMC278 long acting (slowly effective after initial
dosage and maintaining its effects over a long period of time) when administered as an
intramuscular (ie, in to the muscle) injection in adult participants who are seronegative
for human immunodeficiency virus type 1 (HIV-1).
This is an open-label (all people know the identity of the intervention), multi-arm (more
than one treatment group), dose-ranging study (clinical study where different doses of study
medication are tested against each other) to evaluate the safety, acceptability,
pharmacokinetics, and ex vivo pharmacodynamics of a single and multiple intramuscular
injections of long acting TMC278 to human immunodeficiency virus type 1 (HIV-1) seronegative
(having a negative serum reaction) male and female participants. The study consists of 3
phases including screening phase, treatment phase, and the follow up phase (approximately 4
to 6 months after the first dose of study medication). In treatment phase, enrolled
participants will be divided in to 2 arms, ie, Arm A (female participants) which will be
further divided in to Arm 1A, Arm 2A, Arm 3A, Arm 4A, and Arm 5A with 12 female participants
per arm; and Arm B (male participants) which will be further divided in to Arm 1B, Arm 2B,
Arm 3B, Arm 4B, and Arm 5B with 6 male participants per arm. Safety evaluations will include
assessment of adverse events, clinical laboratory tests, electrocardiogram, physical
examination, and vital signs which will be monitored throughout the study. The total
duration of study for each participant will be approximately 5 to 7 months.
than one treatment group), dose-ranging study (clinical study where different doses of study
medication are tested against each other) to evaluate the safety, acceptability,
pharmacokinetics, and ex vivo pharmacodynamics of a single and multiple intramuscular
injections of long acting TMC278 to human immunodeficiency virus type 1 (HIV-1) seronegative
(having a negative serum reaction) male and female participants. The study consists of 3
phases including screening phase, treatment phase, and the follow up phase (approximately 4
to 6 months after the first dose of study medication). In treatment phase, enrolled
participants will be divided in to 2 arms, ie, Arm A (female participants) which will be
further divided in to Arm 1A, Arm 2A, Arm 3A, Arm 4A, and Arm 5A with 12 female participants
per arm; and Arm B (male participants) which will be further divided in to Arm 1B, Arm 2B,
Arm 3B, Arm 4B, and Arm 5B with 6 male participants per arm. Safety evaluations will include
assessment of adverse events, clinical laboratory tests, electrocardiogram, physical
examination, and vital signs which will be monitored throughout the study. The total
duration of study for each participant will be approximately 5 to 7 months.
Inclusion Criteria:
- Human immunodeficiency virus type 1 (HIV-1) seronegative at screening and enrollment
- Not pregnant or breastfeeding females
- Agrees to protocol-defined method of contraception
- Abstinence from insertion of anything in rectum (eg, medication, enema, penis, or sex
toy) for 72 hours before and 72 hours after each rectal biopsy visit
- Abstinence from insertion of anything in vagina (eg, tampon, medication, douche,
penis, or sex toy) for 72 hours before and 72 hours after each cervical and vaginal
biopsy visit
Exclusion Criteria:
- Post-exposure prophylaxis for HIV exposure within 6 months prior to screening and
known HIV-infected partners
- Use of systemic immunomodulatory medications within the 4 weeks prior to the
enrollment
- Use of vaginally or rectally administered medications or products (including condoms)
containing Nonoxynol-9 (N-9) within the 4 weeks prior to the enrollment
- Abnormalities of the cervical, vaginal, or colorectal mucosa, or significant
symptom(s), which in the opinion of the clinician represents a contraindication to
protocol-required biopsies
- History of recurrent urticaria
- History of or electrocardiogram demonstrating prolonged QT interval
- History of significant gastrointestinal bleeding
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