Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TMC278, Long acting · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1A | EXPERIMENTAL | Female participants will receive a single dose of long acting TMC278 1200 mg intramuscularly (IM) at baseline (Day 0) in Arm 1A. |
| Arm 1B | EXPERIMENTAL | Male participants will receive a single dose of long acting TMC278 1200 mg IM at baseline in Arm 1B. |
| Arm 2A | EXPERIMENTAL | Female participants will receive a single dose of long acting TMC278 600 mg IM at baseline in Arm 2A. |
| Arm 2B | EXPERIMENTAL | Male participants will receive a single dose of long acting TMC278 600 mg IM at baseline in Arm 2B. |
| Arm 3A | EXPERIMENTAL | Female participants will receive 3 bi-monthly injections of long acting TMC278 1200 mg IM at baseline, Months 2 and 4 in Arm 3A. |
| Arm 3B | EXPERIMENTAL | Male participants will receive 3 bi-monthly injections of long acting TMC278 1200 mg IM at baseline, Months 2 and 4 in Arm 3B. |
| Arm 4A | EXPERIMENTAL | Female participants will receive a single dose of long acting TMC278 1200 mg IM at baseline followed by TMC278 900 mg at Months 2 and 4 in Arm 4A. |
| Arm 4B | EXPERIMENTAL | Male participants will receive a single dose of long acting TMC278 1200 mg IM at baseline followed by TMC278 900 mg at Months 2 and 4 in Arm 4B. |
| Arm 5A | EXPERIMENTAL | Female participants will receive a single dose of long acting TMC278 1200 mg IM at baseline followed by TMC278 600 mg at Months 2 and 4 in Arm 5A. |
| Arm 5B | EXPERIMENTAL | Male participants will receive a single dose of long acting TMC278 1200 mg IM at baseline followed by TMC278 600 mg at Months 2 and 4 in Arm 5B. |
| Name | Type | Description |
|---|---|---|
| TMC278, Long acting (LA) | DRUG | TMC278 long acting will be administered IM to the participants as follows: a single dose of TMC278 600 mg will be administered at baseline in Arm 2A and Arm 2B; at Months 2 and 4 in Arm 5A and Arm 5B. A single dose of TMC278 900 mg will be administered at Months 2 and 4 in Arm 4A and Arm 4B. A single dose of TMC278 1200 mg will be administered at baseline in Arm 1A, Arm 1B; Arm 3A, Arm 3B, Arm 4A, Arm 4B, Arm 5A and Arm 5B; at Months 2 and 4 in Arm 3A and Arm 3B. |
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...
TMC278 Long Acting is an investigational long-acting formulation of the small molecule TMC278, being studied in healthy volunteers. It is being evaluated for safety, acceptability, pharmacokinetics, and ex vivo pharmacodynamics in HIV-1 seronegative participants. The drug is in Phase 1 clinical development.
TMC278 Long Acting is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is conducting clinical research on this long-acting formulation of TMC278 in healthy volunteers.
TMC278 Long Acting is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the drug's safety, acceptability, pharmacokinetics, and ex vivo pharmacodynamics in HIV-1 seronegative participants. The drug is investigational and not yet approved.
TMC278 Long Acting has one completed clinical trial, NCT01656018, titled 'A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants.' This Phase 1 study enrolled 4 healthy participants in the United States.
TMC278 Long Acting is a long-acting formulation of TMC278, which is the active pharmaceutical ingredient. The long-acting version is designed to provide extended release of the drug. The clinical trial for TMC278 Long Acting specifically evaluates this formulation in healthy volunteers.